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Classification of IVD medical devices

Version 1.1 November 2011

Overview

The medical devices regulatory framework has a separate classification system for IVD medical devices (IVDs). Under this system, IVD medical devices are classified according to the risk posed to the health of the public or an individual, and relates to the risk of an incorrect result arising from the use of the IVD.

The detailed legislation describing the classification of IVDs can be found in:

• Regulation 3.1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
• Subregulations 3.2 (2) and 3.3 (2) of the Regulations
• Schedule 2A of the Regulations.

IVDs are classified according to subregulation 3.3 (2) as follows:

Classification	Level of risk
Class 1 IVD	no public health risk or low personal risk
Class 2 IVD	low public health risk or moderate personal risk
Class 3 IVD	moderate public health risk or high personal risk
Class 4 IVD	high public health risk

The same classification rules apply to both commercial IVDs and in-house IVDs.

The manufacturer is responsible for determining the class of an IVD using the classification rules in Schedule 2A and having regard to:

The manufacturer is responsible for determining the class of a device using a set of classification rules with regard to:

• the manufacturer's intended use of the device; and
• the level of risk to the patient and the public (taking into account the likelihood of harm and the severity of that harm).

Identical devices may be classified differently if they are to be used for different diagnostic purposes. This is why the manufacturer's intended use of the device is critical to determining the appropriate class. The intended use can be obtained from the:

• Information provided with the IVD (including Instructions for Use and labelling)
• Advertising materials
• Design dossier (if applicable).  

Please note: There are IVD medical devices where the classification in Australia may be different to the classification in other countries. Australia has aligned the principles for classification of IVDs with those of the Global Harmonisation Task Force (GHTF); however the manufacturer should take into account Australian legislation when determining the classification of a device that is to be supplied in Australia.

Principles for applying the classification rules

The classification rules are outlined in Schedule 2A of the Regulations and are based on the manufacturer's intended purpose, taking into account the degree of risk involved to the patient and the public. The classification must be consistent with the information accompanying the IVD including the labels, Instructions for Use, brochures and operating manuals. If the intended purpose of the device is not clear, the TGA will request further clarification from the manufacturer and may also consider the purpose generally accepted in clinical and laboratory practice.

All the classification rules must be considered to determine the classification of the IVD. In some cases, more than one classification rule may be applicable to an IVD, but if this occurs the higher risk classification applies -see subregulation 3.3(7). There are exceptions to this principle, whereby a number of the classification rules state that despite certain other rules, a particular risk classification should always apply to a type of IVD. These include for example, Rule 1.5 which specifies that IVDs that are non assay-specific quality control material are Class 2 IVDs; or Rule 1.8 which specifies that IVDs for export only are classified as Class 1 IVDs.

A number of IVDs are supplied with, or are required to be used in combination with, other IVDs, non-IVD medical devices or accessories to medical devices. The classification rules must be applied separately to each device. An accessory to an IVD is described as an item that its manufacturer specifically intends to be used together with an IVD, to enable that IVD to be used as intended. Accessories are classified independently of the IVD that they are to be used with -see subregulation 3.3 (4).

Materials that are intended to be used for the calibration or quality control of a particular named assay are considered to be part of a single assay with a common intended purpose. Therefore they have the same risk classification as each of the other assay components based on the common intended purpose of the assay, even if these materials are sold separately.

If one or more IVDs are supplied as part of a system or a procedure pack, the class for the entire pack is the highest class of any individual IVD in the pack. For example, if a procedure pack contains a selection of Class 1, 2 and 3 IVDs, then the entire pack is classified as a Class 3 IVD.

If a procedure pack contains a mixture of IVDs and non-IVD medical devices, the individual component of the highest Class will determine the overall classification of the procedure pack; the equivalence of IVD and non-IVD classifications is prescribed in regulation 3.1. The individual device of the highest Class will also determine if the procedure pack is to be included in the ARTG as an IVD medical device or a non-IVD medical device - see subregulation 3.3(9). For example, a procedure pack contains a portable prothrombin time meter (Class 1 IVD), test strips or cartridges for prothrombin time self-testing (Class 3 IVD), and a lancet (Class IIa medical device) for obtaining a blood specimen. The procedure pack would take on the highest classification assigned to any individual component, namely Class 3 IVD, and is required to be included in the ARTG as an IVD medical device. When an IVD and a medical device within a procedure pack are of the same classification level (equivalent risk class) subregulation 3.3 (10) applies and the primary intended purpose of the device is to be considered to determine whether the pack is included on the ARTG as an IVD or a medical device. Where components of a procedure pack are also supplied separately, they need to be separately included in the ARTG, e.g. Medical devices such as lancets.

For more information on systems and procedure packs, please see Section Systems and Procedure packs in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Classification rules

Flowchart

Classification Rule 1.1 - Detection of transmissible agents posing a high public health risk

Rationale

Devices captured by this rule pose a high public health risk.

Rule 1.1 is presented in two parts - paragraph 1.1 (a) describes IVDs that are used to establish the safety of blood and blood components for transfusion, or cells, tissues and organs for transplantation. In most cases, the result of the test is a major determinant as to whether the donation or product will be used.

Paragraph 1.1 (b) describes IVDs that are used to diagnose clinical infections that cause serious diseases with a high risk of transmission from person to person in the Australian population.

Serious diseases are defined in Regulation 1.3 as those:

• that may result in death or long-term disability; and
• that are often incurable or require major therapeutic interventions; and
• where an accurate diagnosis is of vital importance to mitigate the public health impact of the condition. 

Rule 1.1 applies to all assays used to determine suitability for transfusion or transplantation as part of the laboratory's infectious disease testing algorithm, and includes front-line or screening assays, confirmatory assays, supplemental assays, and IVDs that detect structural components or surrogate markers of transmissible agents that cause serious disease.

Some IVDs are intended only to be used in a diagnostic setting but are identical to those intended to be used for screening blood and tissue donations. These IVDs may be classified according to other rules if Rule 1.1 (b) does not also apply, provided the Sponsor can provide assurance that the IVD is marketed in accordance with the alternate classification. For example, a syphilis assay can be classified as a Class 4 IVD if it is intended to screen blood and tissue donations, but is a Class 3 IVD as per rule 1.3 (1) (a) if it is intended for diagnostic purposes only.

Examples

• All tests used by the Australian Red Cross Blood Service for testing of the blood supply are Class 4 IVDs, including screening and confirmatory assays for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis B virus, HTLV I/II and syphilis. Any additional assays that are performed on a supplementary basis, such as those use to determine Cytomegalovirus status or suitability for Zoster immunoglobulin production, are also Class 4 IVDs.
• All tests used by hospital-based laboratories that screen for infectious disease markers to determine suitability for organ or tissue transplantation under the requirements of their GMP licence are Class 4 IVDs, including screening and confirmatory assays for HIV, HCV, Hepatitis B virus, HTLV I/II and syphilis.
• Pyrogenicity tests (endotoxin activity assays) marketed for detection of bacterial contamination of blood components are Class 4 IVDs if the result of the test is a determinant as to whether or not the product will be used.  By contrast, if the test is used for quality control purposes to measure the rate of contamination in a sample of products as part of the manufacturing process, then the test would be considered a manufacturing step and not an IVD.
• All assays for the clinical diagnosis of infection by HIV 1 & 2, Hepatitis C virus, Hepatitis B virus and HTLV I/II are Class 4 IVDs. Assays for the clinical diagnosis of Hepatitis B virus are taken to include the following infectious disease markers: Hepatitis B surface antigen (HBsAg), Hepatitis B core IgM antibodies (anti-HBcore IgM), Hepatitis B core total antibodies (anti-HBcore tot) and Hepatitis B virus nucleic acid detection (HBV NAT).
• Tests for detection of severe acute respiratory syndrome-associated coronavirus (SARS-CoV), highly virulent pandemic influenza, Variola virus (Smallpox virus) and viral haemorrhagic fevers such as Ebola virus or Marburg virus are Class 4 IVDs.  

Classification Rule 1.2 - Detection of red blood cell antigens and antibodies and non red cell typing

Rationale

Devices captured by this rule present a high individual risk, where an erroneous result would put the patient in an imminent life-threatening situation.

Classification rule 1.2 divides blood grouping IVDs into two subsets depending on the nature of the blood group antigen the IVD is designed to detect, and its importance in a transfusion setting. Essentially, all IVDs for testing for antigens or antibodies for any of the red blood cell markers not specifically mentioned in Rule 1.2 (2), and all IVDs used in tissue typing to test for human leukocyte antigens and antibodies, are Class 3 IVDs. The red blood cell markers captured by rule 1.2 (2) are critical to ensuring safe transfusion of blood and blood components, or transplantation of cells, tissues and organs, and are Class 4 IVDs.

Examples

• IVDs for testing for red blood cell antigens or antibodies from Blood Group A, Blood Group B, or Blood Group AB, within the ABO blood group system are Class 4 IVDs.
• IVDs for testing for red blood cell antigens or antibodies for Cw or V from the Rhesus system; Cellano (k) from the Kell blood group system; or any markers from MNS or Cartwright blood group systems are Class 3 IVDs.
• All IVDs used in tissue typing, to detect antigens and antibodies for any human leukocyte antigens are Class 3 IVDs.

Classification Rule 1.3 - Detection of transmissible agents or biological characteristics posing a moderate public health risk or a high personal risk

Rationale

IVDs captured by this rule present a moderate public health risk or a high individual risk, where an erroneous result could lead to a patient management decision resulting in a significant impact on patient outcome. These IVDs usually provide the critical or sole determinant for correct diagnosis.

The Australian National Notifiable Diseases Surveillance System (NNDSS) publishes a list of diseases that are required to be notified nationally. The list is available on the Australian Government Department of Health and Ageing website. A case definition is provided for each disease or disease group and a number of the case definitions rely on laboratory definitive evidence, laboratory suggestive evidence, clinical evidence (probable cases), or a combination of various markers to be present to require their notification. Contribution to the diagnosis of a particular disease through the results of testing for any of the markers mentioned as either suggestive or definitive evidence, are taken to be Class 3 IVDs. Where information presented in the Instructions for Use for a particular assay represents that an additional marker (beyond those specified in the case definitions) may also be used to diagnose a notifiable disease, these too are taken to be Class 3 IVDs.

IVDs that are used to detect the presence of, or exposure to, sexually transmitted agents are Class 3 IVDs. The Australian Government has in place a national strategy which aims to reduce the transmission of sexually transmitted infections in Australia. The Second National Sexually Transmissible Infections Strategy 2010-2013 is available on the Department of Health and Ageing website. In addition to tests for HIV, HCV and Hepatitis B virus which are regarded as serious diseases in Australia (and are therefore Class 4 IVDs), the second National STI Strategy 2010-2013 continues and expands the work of the first strategy and discusses eight sexually transmitted infections of national importance as follows (with causative organisms provided in parentheses): gonorrhoea (Neisseria gonorrhoeae), chlamydia (Chlamydia trachomatis), syphilis (Treponema pallidum), donovanosis (Klebsiella (Calymmatobacterium) granulomatis), genital herpes (Herpes simplex virus 2), lymphogranuloma venereum (C. trachomatis L-1, L-2, L-3), genital warts (Human papillomavirus) and trichomoniasis (Trichomonas vaginalis).

Examples:

• Tests to detect the presence or exposure to a sexually transmitted agent such as C. trachomatis or N. gonorrhoea are Class 3 IVDs. Although the detection of antibodies to C. trachomatis does not fulfil the NNDSS case definition for notification of chlamydia under Rule 1.3 (2), antibodies to C. trachomatis may be used to indicate either current or previous infection and therefore are also regarded as a Class 3 IVD under Rule 1.3 (1) (a). Tests for the detection of Chlamydia species to the genus level and for Chlamydia pneumoniae only are not captured by this rule, and would be regarded as Class 2 IVDs.
• IVDs used to detect in cerebrospinal fluid or blood, the presence of an infectious agent that has a risk of limited propagation include the following as Class 3 IVDs: tests for the direct detection of N. gonorrhoea or Cryptococcus neoformans antigens; tests for the detection of Haemophilus influenzae type B (Hib) antigen; tests for the detection of IgM antibodies to malaria parasites.
• Tests that are used to detect the presence of an infectious agent, whereby an erroneous result would cause death or severe disability to the individual or foetus being tested are Class 3 IVDs. This includes tests for emerging serious diseases such as Hendra virus, or tests to confirm the presence or identity of methicillin-resistant Staphylococcus aureus (MRSA), either directly from a clinical specimen or from a cultured isolate (note that microbiological culture media is a Class 1 IVD under Rule 1.7). This rule also applies to other serious infectious diseases such as prion diseases or malaria, many of which are also included in the NNDSS list.
• Prenatal screening tests include a number of different analytes which together generate a testing profile for infections that may cause illness in pregnant women, and birth defects or serious infections in newborns. These tests are sometimes collectively referred to as a TORCH screen and are regarded as Class 3 IVDs. Tests usually include detection of antibodies to Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV), Herpes simplex virus 1 & 2, Measles virus and Treponema pallidum.
• Tests that are used to select patients for selective therapy and management are Class 3 IVDs and include viral genotyping assays to establish a suitable course of therapy, or Her2/neu testing to select patients with breast cancer for treatment using the drug Herceptin.
• Tests for tumour markers such as free prostate specific antigen (free PSA), or tests where results are expressed as a percentage or ratio against total PSA for use in differentiating between benign or malignant tumours are Class 3 IVDs.
• Rule 1.3 (f) includes a note which describes tests where a therapy decision is only made after further investigation, or that are used for monitoring. Tests intended to be used for initial screening, such as a faecal occult blood screening test (FOBT) for bowel cancer, require further investigation if a positive result is obtained; and tests used only for monitoring disease status, such as a total PSA which may aid in the management of a prostate cancer patient are regarded as Class 2 IVDs under Rule 1.7.
• Pharmacogenetic tests to predict metabolism of warfarin, or tests for other cytochrome P450 oxidative enzymes which may be used to gauge the metabolism rate of drugs are Class 3 IVDs.
• All tests used for human genetic testing are Class 3 IVDs, for example tests for detecting the Philadelphia chromosome, Huntington's disease or cystic fibrosis.
• Tests for therapeutic monitoring of immunosuppressive medicines such as cyclosporin and tacrolimus are Class 3 IVDs, due to the impact of an erroneous result on a patient and the potential for adverse transplantation outcome. Other tests for monitoring substances or biological components that are regarded as Class 3 IVDs include acute cardiac markers such as Troponin I, Troponin T and CKMB.
• Class 3 IVDs used for the management of life-threatening infectious disease include viral load and genotyping assays for HIV and Hepatitis C virus.
• Class 3 IVDs used for screening for congenital disorders include pre- and post-natal tests for trisomy 13, trisomy 18, trisomy 21 or Klinefelter's syndrome; tests for alpha-fetoprotein (AFP) when used in the detection of foetal open neural tube defects.
• Software that is supplied as a "stand-alone" IVD, for use in the interpretation of a series of results obtained as part of a first trimester screening assessment, in order to determine foetal risk of trisomy 21 is a Class 3 IVD.Software that is supplied as a "stand-alone" IVD, for use in staging or predicting severity of disease by means of an algorithm based on a combination of anthropometric measures and non-invasive biomarkers is a Class 3 IVD.

Classification Rule 1.4 - IVD medical devices for self-testing

Rationale

Self-testing IVDs are intended to be used by individuals with no scientific or technical expertise, or formal training in a medical field or discipline to which the test relates. Self-test devices can pose a low, moderate or high personal risk and can therefore fall into Class 1, 2 or 3.

The definition of IVD medical device for self-testing as prescribed under regulation 1.3, includes IVDs intended for use in the collection of a sample by a lay person and, if the sample is tested by another person (e.g. a laboratory) the results are returned directly to the person from whom the sample was taken without the direct supervision of a health professional who has formal training in a medical field or discipline to which the test relates. The TGA interprets 'direct supervision' to mean written or verbal communication from a health professional who is personally treating the person and therefore has already established a professional relationship with their client, or verbal communication with the person by a health professional who is able to explain the significance of the test and answer questions that the person may have regarding the interpretation of the result. This applies regardless of the nature of the result, e.g. positive, negative, quantitative value.

Rule 1.4 classifies IVDs for self-testing as Class 3 IVDs if the condition, ailment or defect to which the test relates is generally considered to be:

• inappropriate to be diagnosed or treated without consulting a health professional
• beyond the ability of the average person to evaluate accurately, or be treated for safely without adequate supervision.

In situations where use of the self test does not determine a serious condition or the result is purely preliminary, other classification rules apply. For example a positive result from a pregnancy self-test kit will generally be followed up with a visit to the user's medical practitioner therefore a pregnancy self test kit is not regarded as a Class 3 IVD, rather it is classified as a Class 2 IVD using rule 1.7. Certain types of self-testing IVDs are prohibited from entry on the ARTG and thus cannot be legally supplied in Australia. Unless they are for use as part of a government-sponsored screening program, are for monitoring a previously diagnosed disease or they are for export only, self-testing IVDs used to test for pathogenic organisms or transmissible agents (including all notifiable infectious diseases), self-testing genetic tests and self-testing IVDs used to test for serious disorders (such as cancer or myocardial infarction) are excluded from being entered on the ARTG. A full description of IVDs that are excluded from entry on the ARTG is contained in the Therapeutic Goods (Excluded purposes) Specification 2010 made under section 41BEA of the Act.

Examples

• System for self-monitoring of blood glucose - Class 3 IVD. Each of the individual components of a self-testing blood glucose monitoring system is classified individually, with the highest overall class applying to the system. So a glucose meter, as an instrument for in vitro diagnostic procedures, is classified as a Class 1 IVD as per rule 1.6, the glucose reagent test strips for use in self-testing are classified as Class 3 IVDs since an erroneous result obtained when self-testing for blood glucose may lead to a life-threatening situation and the lancet for obtaining a blood sample is classified as a Class IIa medical device. As a system intended for self-testing, a glucose meter, glucose reagent test strips and lancet would be classified as a Class 3 IVD.
• Urine self-test strips to detect glucose and other general urine chemistry analytes - Class 2 IVD.
• Pregnancy and fertility self-testing kits - Class 2 IVD.

Classification Rule 1.5 - Non assay-specific quality control material

Rationale

Devices in this class pose a low public health risk or moderate personal risk.

Quality control material is taken to be controls, calibrators and standards, and as a subset of this, non assay-specific quality control materials are those that are not assigned for use with a specific assay.

This rule does not apply to quality control materials that are assigned for use with a specific assay, or where the manufacturer of the quality control material has provided detailed information (e.g. references ranges) relating to a particular assay - these are taken to be the same risk class as the parent assay based on the common intended purpose, even if they are sold separately.

Examples

• Non-assay specific control plasmas for use in coagulation studies.
• Non-assay specific control serum containing multiple biochemical analytes.
• Non-assay specific control serum, for use as an independent control for HCV antibody assays.
• A DNA or RNA probe supplied for use as a non-assay specific control for in situ hybridisation of targeted gene polymorphisms. Although an ISH probe is intended for use in human genetic testing and could therefore be regarded as a Class 3 IVD, under rule 1.5 despite any other classification rule, non-assay specific quality control material is a Class 2 IVD.

Classification Rule 1.6 - Reagents, instruments etc.

Rationale

Devices captured by this rule present a low individual risk and minimal or no public health risk.

Products for general laboratory use are not IVD medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. For example, pipettes, test tubes and general consumables which are not specifically intended by the manufacturer to be used to perform a particular test are not considered IVD medical devices.

Stains are generally considered to be IVDs if they are intended by the manufacturer to be for a diagnostic purpose. Single staining solutions for diagnostic use are classified as Class 1 IVDs under rule 1.6 (1) only if they are supplied separately and without instructions on how to perform a particular staining procedure, because they are regarded as general purpose reagents. If staining solutions are supplied either individually or as a kit, together with instructions linking that stain to a particular staining process, the staining solution or kit must be classified according to the overall intended purpose of the stain.

Stain powders or base ingredients used to prepare stains for use in a diagnostic setting are not considered to be IVDs because they are not finished products. However, once a powder or base ingredients have been made into a stain by a laboratory, the finished staining solution/s would be regarded as an in-house IVD and an appropriate risk classification applied according to the overall intended purpose of the stain.

Due to their interdependence, an instrument or software that is specifically required to be used to perform a particular test will be assessed at the same time as the test kit even though the instrument itself is classified as Class 1 IVD.

Examples

• Grams iodine solution which is individually supplied by a manufacturer without specific instructions for use in a Gram staining procedure is a Class 1 IVD because it may be used in multiple disciplines (eg. Clinical microbiology, histology, cytology). Conversely, a foetal cell staining kit, supplied with instructions for performing a Kleihauer stain to identify candidates required to receive more than one dose of anti-D immunoglobulin is a Class 2 IVD under rule 1.7. A ready-to-use Romanowski staining kit supplied for use in haematology for staining peripheral blood sme-rs to perform white cell differentiation and evaluation of red cell morphology is also a Class 2 IVD under rule 1.7.
• A separately supplied reagent labelled as intended for use with a specific microbial identification testing kit, in order to determine the biochemical identification of a clinical isolate is a Class 2 IVD, in line with the classification of the microbial identification IVD, e.g. 3% hydrogen peroxide for use in a catalase test or tetramethyl-p-phenylenediamine (TMPD) for use in an oxidase test.  Conversely, a general reagent labelled simply as 3% hydrogen peroxide or TMPD, which is not manufactured and supplied specifically for in vitro diagnostic use, is not considered to be an IVD.
• Microscope counting chambers such as haemocytometers and chambered urinalysis slides labelled as being intended for the microscopic examination of urine and other body fluids are Class 1 IVDs because they are suitable for use across multiple disciplines or in several different diagnostic applications. Plain ground-glass microscope slides, although intended for an application related to microscopic analysis, are not generally intended to be used expressly as an IVD medical device.
• Except for specimen containers intended for use in self testing, evacuated or non-evacuated blood collection tubes, and specimen containers intended for the collection of urine, faeces, cell or tissue specimens for subsequent in vitro examination are Class 1 IVDs. General laboratory tubes that are used to contain reactions or to contain and store processed specimens are not considered to be specimen receptacles.
• Manual, automated or semi-automated instruments such as an enzyme immunoassay analyser, an ESR analyser, or a thermal cycler for performing nucleic acid amplification in a clinical specimen are Class 1 IVDs.
• General laboratory equipment such as waterbaths, centrifuges, balances and automatic pipettes are not considered to be IVDs unless they are specifically intended by the manufacturer (in product labelling or accompanying literature) to be used for an in vitro diagnostic examination e.g. blood bank tube centrifuge for spinning of blood grouping reactions.
• Prepared (ready to use) microbiological culture media, including agar containing selecting agents, antimicrobials, chromogenic agents or chemical indicators for colony differentiation are Class 1 IVDs. Dehydrated powders and agar bases are not considered to be IVDs.
• Class 1 IVD General Laboratory reagents are those that are suitable for use across multiple disciplines or a broad range of different purposes. Standard buffers (e.g. PBS) and saline solutions are not considered to be an IVD unless supplied specifically for use as an IVD.
• Non-assay specific instrument consumable reagents are considered to be Class 1 IVDs. For example a wash solution for use on instrument XYZ. The wash solution is not specific to a particular analyte, however is specified for use on instrument XYZ.
• When a separately supplied reagent is intended for use in determining a specific analyte or parameter, or it is for use with a particular IVD, or it has a clearly defined purpose relating to its use with a group of similar or closely related tests, the reagent will be classified according to the class of the analyte or parameter it is intended to be used with. For example, a diluent or lyse solution intended for use when performing a full blood count (FBC) will be classified according to the class of the FBC assay, that is, a Class 2 IVD; a kit or individually supplied reagents intended to be used for the in-situ hybridisation of targeted gene polymorphisms, are classified under rule 1.3 as Class 3 IVDs for human genetic testing.
• A non-assay specific bacterial or viral RNA nucleic acid extraction kit intended for the extraction of pathogenic nucleic acid from a clinical specimen is a Class 2 IVD; a kit with a similar intended purpose of non-assay specific bacterial or viral RNA extraction, but which is dedicated for use on a specific instrument would be a Class 1 IVD. 

Classification Rule 1.7 - Other IVDs are Class 2 IVD medical devices

Rationale

Devices captured by this rule present a moderate individual risk or a low public health risk.

An erroneous result is unlikely to have a significant negative impact on patient outcome. The devices captured by this rule rarely provide the sole determinant for the correct diagnosis. If it is the sole determinant other information is available such as presenting signs and symptoms or clinical information, which may guide the physician.

This class also includes IVDs that detect infectious agents that are not easily propagated in a population.

Examples

• Most biochemistry tests for blood gases, hormones, vitamins, enzymes, metabolic markers and substrates are Class 2 IVDs.
• IVDs for performing coagulation testing are generally regarded as Class 2 IVDs, including activated partial thromboplastin time (APTT), factor assays and prothrombin time testing (other than prothrombin time for self-testing, which is captured as a Class 3 IVD by rule 1.4).
• Biochemical tests for establishing the presumptive identification of microbiological culture isolates, or for determining antimicrobial susceptibility of microbiological culture isolates, are Class 2 IVDs; however, confirmatory identification or serotyping reagents for microbiological culture isolates are classified according to the analyte being detected, e.g. Salmonella poly-O antisera or Haemophilus influenza serotype b typing reagent are Class 3 IVDs as they are specific for diseases included in the Australian National Notifiable Diseases Surveillance System (NNDSS) list.
• Cell culture lines for the culture of viruses present in clinical specimens are Class 2 IVDs.
• Tests to detect infection by Helicobacter pylori, Clostridium difficile, Adenovirus, Rotavirus and Giardia lamblia are Class 2 IVDs.
• Pregnancy tests for self-testing are Class 2 IVDs.

Classification Rule 1.8 - IVD medical devices intended for export only

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