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Classification of IVD medical devices

4 December 2020

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IVD classification examples

Detection of transmissible agents posing a high public health risk

Rule: 1.1 (a or b) Class: 4

  • All tests intended to be used for blood, organ and tissue donor screening, including screening and confirmatory assays for:
    • Human immunodeficiency virus (HIV)
    • Hepatitis C virus (HCV)
    • Hepatitis B virus
    • HTLV I/II
    • Syphilis.
  • Any additional assays used to screen donors on a supplementary basis, such as those used to determine Cytomegalovirus status or to screen for Malaria.
  • Tests intended to be used to screen for HIV and Hepatitis B and C, either at the point of care or for self-testing.
  • Tests intended for the diagnosis of infection with, or exposure to:
    • Highly virulent pandemic influenza
    • Variola virus (Smallpox virus)
    • Viral haemorrhagic fevers, such as Ebola virus or Marburg virus.
  • All tests intended for the diagnosis of infection with, or exposure to:
    • HIV 1 & 2
    • Hepatitis C virus
    • Hepatitis B virus*
    • HTLV I/II

Note: Applies to first-line assays, confirmatory assays and supplemental assays.

*Assays for Hepatitis B markers that are intended by the manufacturer to be used as an aid in the diagnosis of acute or chronic infection, or exposure to Hepatitis B, e.g.:

  • Hepatitis B surface antigen (HBsAg)
  • Hepatitis B core IgM antibodies (anti-HBcore IgM)
  • Hepatitis B core total antibodies (anti-HBcore tot)
  • Hepatitis B virus nucleic acid detection (HBV NAT)
  • Other tests for Hepatitis B, including anti-HBs would be considered Class 4 IVDs if the manufacturer's intended purpose for the device included aiding in the diagnosis of Hepatitis B.

Detection of red blood cell antigens and antibodies and non-red cell typing

Rule: 1.2 Class: either 3 or 4

IVDs intended for detecting red blood cell antigens, antibodies or genetic markers specific to the following high risk blood groups:

  • ABO system - ABO1 (A), ABO2 (B), ABO3 (AB)
  • Rhesus system - RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e)
  • Kell system - KEL1 (K)
  • Kidd system - JK1 (Jka), JK2 (Jkb)
  • Duffy system - FY1 (Fya), FY2 (Fyb).
  • IVDs intended 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
    • any markers from MNS or Cartwright blood group systems.
  • All IVDs intended for use in tissue typing to detect antigens and antibodies for any human leukocyte antigens.
  • IVDs intended for subtyping previously determined ABO system A group reactive patients (i.e. A1, A2, A3 etc.).
  • Tests intended for the quantitative determination of antibodies to Rhesus system blood group antigens (i.e. anti-D).

Detection of transmissible agents or biological characteristics

(Posing moderate public health risk or high personal risk)

Rule: 1.3 Class: 3

  • Tests intended to detect the presence or exposure to a sexually transmitted agent, such as:
    • Neisseria gonorrhoeae
    • Chlamydia trachomatis
    • Syphilis (Treponema pallidum)
    • Donovanosis (Klebsiella (Calymmatobacterium) granulomatis)
    • Herpes simplex virus 1 & 2
    • Lymphogranuloma venereum (C. trachomatis L-1, L-2, L-3)
    • Human papillomavirus
    • Trichomoniasis (Trichomonas vaginalis).
  • Tests intended to detect (in cerebrospinal fluid or blood) the presence of an infectious agent that poses a high personal risk and has a risk of limited propagation, including tests for the:
    • direct detection of Cryptococcus neoformans antigens
    • detection of N. meningitidis in CSF or blood
    • detection of Haemophilus influenzae type B (Hib) antigen
    • detection of IgM antibodies to malaria parasites
    • detection of Prion diseases
    • detection of Hendra virus.
  • Tests that are intended to detect the presence of an infectious agent and where an incorrect result could cause death or severe disability to the individual or foetus being tested, such as tests to:
    • confirm the presence or identity of methicillin-resistant Staphylococcus aureus (MRSA), either directly from a clinical specimen or from a cultured isolate.
    • detect transmissible agents that cause serious infectious diseases such as influenza, typhoid fever and pertussis.
    • specifically detect/identify Salmonella typhi, including serotyping reagents intended to identify Samonella typhi at the subspecies level (e.g., a serotyping kit intended to discriminate between S. typhi and S. paratyphi).
    • detect Shiga toxin-producing E. coli or Verotoxin‑producing E. coli (STEC or VTEC) including serotyping reagents to specifically identify E.coli 0157:H7 (e.g., 0157 and H7 antisera).
  • Tests to detect Influenza A including tests intended to:
    • screen for influenza A (e.g., detection of matrix protein)
    • detect or type an influenza A infection by different hemagglutinin subtypes and neuraminidase subtypes (e.g., H1 through H18 and N1 through N11 respectively)
    • detect or type certain influenza A strains (e.g., H1N1, H5N1)
    Only tests specifically intended to detect highly virulent pandemic strains that pose a high public health risk would be considered Class 4 IVDs.
  • Screening tests intended to determine prenatal immune status for infections that may cause illness in pregnant women and birth defects, or serious infections in newborns, such as the detection of antibodies for:
    • Toxoplasma gondii
    • Rubella virus
    • Cytomegalovirus (CMV)
    • Herpes simplex virus 1 & 2
    • Measles virus
    • Treponema pallidum.
    Note: If tests to detect immune status for these infections are not specifically intended for prenatal screening, they are classified according to other rules.
  • Tests intended to determine infective disease status or immune status where there is a risk that an incorrect result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient such as tests for the detection of CMV IgG in transplant patients.
  • Tests that are intended to be used to select patients for selective therapy and management, such as:
    • Viral genotyping assays to establish a suitable course of therapy
    • Her2/neu testing to select patients with breast cancer for treatment using the drug Herceptin.
  • Tests intended to detect tumour markers, or to aid in the diagnosis of cancer, such as:
    • free prostate specific antigen (free PSA)
    • carcinoembryonic antigen (CEA)
    • human chorionic gonadotropin (hCG)
    • cancer antigen (CA) 15-3, CA125.
  • Pharmacogenetic tests intended to predict metabolism of warfarin, or tests for other cytochrome P450 oxidative enzymes which may be used to gauge the metabolism rate of drugs.
  • All tests intended for human genetic testing (whether testing for an inherited or acquired genetic marker), including:
    • prenatal genetic screening
    • tests for detecting the Philadelphia chromosome
    • tests for Huntington's disease
    • test for cystic fibrosis
    • FISH probe to detect the BCR-ABL translocation.
  • Tests intended for therapeutic monitoring of immunosuppressive medicines such as, cyclosporin and tacrolimus, due to the impact of an incorrect result on a patient and the potential for adverse transplantation outcome.
  • Tests for monitoring biological components including acute cardiac markers such as, Troponin I, Troponin T and CKMB.
  • Tests intended for the management of life-threatening infectious disease include viral load and genotyping assays for HIV and Hepatitis C virus.
  • Tests intended for screening of congenital disorders, including 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 example software for the interpretation of results obtained as part of a first trimester screening assessment to determine foetal risk of trisomy 21.
  • Rule 1.3 (f) includes a note which clarifies the classification of tests used in the diagnosis or treatment of cancer, where a therapy decision is only made after further investigation, or that are used for monitoring.

    The following examples would therefore be considered Class 2 IVDs:

    • 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.
    • tests used only for monitoring disease status, such as a total PSA which may aid in the management of a prostate cancer patient.
  • Chlamydia tests that are only intended to detect to the genus level (and not to the species level) are Class 2 IVDs under Rule 1.7.
  • Individually supplied serotyping reagents to identify markers that assist in the characterisation of Salmonella at the species level, but do not in themselves specifically identify S. typhi, (e.g., monovalent and polyvalent O antisera and H antisera).

IVDs for self-testing

Rule: 1.4 Class: 3

  • System for the self-monitoring of blood glucose.

    Each device is classified individually, with the highest class applying to the overall system:

    • the glucose meter is classified as a Class 1 IVD as per rule 1.6
    • the glucose reagent test strip is a Class 3 IVD because an incorrect result obtained when self-testing for blood glucose may lead to a life-threatening situation
    • the lancet is a Class IIa medical device
  • Prothrombin time reagent test strips for the self-monitoring of the effects of anticoagulation therapy.
  • Tests that do not determine a serious condition (and where the results are preliminary) are Class 2 IVDs:
    • Pregnancy and fertility self-testing kits
    • Urine self-test strips to detect glucose and other general urine chemistry analytes
  • A self-test for HIV is a Class 4 IVD as it is a screening test for a serious disease and Classification Rule 1.1b applies (i.e., higher classification rule applies).

Non-assay specific quality control material

Rule: 1.5 Class: 2

  • Non-assay specific control plasmas for use in coagulation studies.
  • Non-assay specific control serum containing multiple biochemical analytes.
  • Non-assay specific control serum, intended for use as an independent control for HCV antibody assays.
  • A DNA or RNA probe supplied for use as a non-assay specific normal control for in situ hybridisation (ISH).

Reagents, instruments

Rule: 1.6 Class: 1

  • Microscope counting chambers, such as haemocytometers and chambered urinalysis slides labelled as being intended for the microscopic examination of urine and other body fluids.

    Note: Plain ground-glass microscope slides, although intended for an application related to microscopic analysis, are not IVDs unless specifically intended for diagnostic use.

  • 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, cells or tissue specimens for subsequent in vitro examination.

    Note: 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 intended for use as an IVD such as an enzyme immunoassay analyser, or an ESR analyser.
  • Prepared (ready to use) microbiological culture media, including agar containing selecting agents, antimicrobials, chromogenic agents or chemical indicators for colony differentiation.

    Note: Dehydrated powders and agar bases are not considered to be IVDs.

  • Non-assay specific instrument consumable reagents, e.g. 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.

    Note: Standard buffers (e.g. PBS) and saline solutions are not considered to be an IVD unless intended specifically for use as an IVD.

Single staining solutions for diagnostic use can be classified as Class 1 IVDs under rule 1.6 (1) only if they are intended as general purpose reagents:

  • e.g. grams iodine solution which is intended by the manufacturer for in vitro diagnostic use as a general purpose stain.

If staining solutions are supplied for a specific purpose, either individually or as a kit, the staining solution or kit must be classified according to the overall intended purpose of the stain or kit (see examples for Class 2 IVDs).

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 is an in-house IVD, and an appropriate risk classification must be applied according to the overall intended purpose of the stain.

Other IVDs are Class 2 IVD medical devices

Rule: 1.7 Class: 2

  • A foetal cell staining kit intended for performing a Kleihauer stain to identify candidates required to receive more than one dose of anti-D immunoglobulin.
  • A ready-to-use Romanowski staining kit intended for use in haematology for staining peripheral blood smears to perform white cell differentiation and evaluation of red cell morphology.
  • A non-assay specific bacterial or viral RNA nucleic acid extraction kit intended for the extraction of pathogenic nucleic acid from a clinical specimen.
  • Most biochemistry tests for blood gases, hormones, vitamins, enzymes, metabolic markers and substrates.
  • IVDs for performing coagulation testing, 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).
  • Cell culture lines for the culture of viruses present in clinical specimens.
  • Pregnancy tests for self-testing.
  • Tests to detect infection by:
    • Helicobacter pylori
    • Clostridium difficile
    • Adenovirus
    • Rotavirus
    • Giardia lamblia.
  • Screening tests intended to presumptively detect Salmonella at the genus/species level such as individually supplied serotyping reagents that are not intended to identify an individual subspecies/serotype in their own right (e.g., polyvalent and monovalent O antisera).

    The majority of individually supplied antisera would therefore be Class 2, even if the combination of results could lead, for example, to a diagnosis of S. typhi.

    Note: Confirmatory identification for microbiological culture using specific serotyping reagents, are classified according to the analyte being detected. For example, serotyping reagents to specifically detect/identify Salmonella typhi at the subspecies level (e.g., a serotyping kit intended to discriminate between S. typhi and S. paratyphi) or Haemophilus influenza serotype b are Class 3 IVDs.

  • Biochemical tests for establishing the presumptive identification of microbiological culture isolates, or for determining antimicrobial susceptibility of microbiological culture isolates.
  • Tests used to detect transmissible agents that have public health importance but pose a moderate personal risk because they generally cause self-limiting disease:
    • Cryptosporidiosis
    • Campylobacter
    • Hepatitis A virus
    • Salmonella enteritidis
    • Mumps
    • Varicella zoster virus (unless intended for prenatal screening)
    • Barmah Forest virus
    • Chikungunya virus
    • Ross River virus
    • Ornithosis
    Note: IVDs to detect the above infectious organisms are included in the Australian National Notifiable Diseases Surveillance System (NNDSS) list and were previously classified as Class 3 IVDs.

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