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Conformity assessment procedures for immunohaematology reagents
Version 1.0, February 2012
Classification of immunohaematology reagents
General guidance on the classification of IVDs can be found in the guideline Classification of IVD medical devices on the TGA website. A limited number of classification rules specified in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations, 2002 (the Regulations) are applicable to IHRs. Classification rule 1.2 divides blood grouping IVDs into 2 subsets depending on the nature of the blood group antigen or antibody and its importance in a transfusion setting.
Classification rule 1.2 (2) specifies IVDs that are Class 4 IVDs or Class 4 in-house IVDs. IHRs are Class 4 IVDs if they are intended to be used to detect any of the markers specified for the following blood group systems:
- ABO system - A0BO1 (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); and
- Duffy system - FY1 (Fya), FY2 (Fyb)
Classification rule 1.2 (1) specifies that IVDs are Class 3 IVDs or Class 3 in-house IVDs if they are intended to be used for the detection of biological markers in order to assess the immunological compatibility of blood, blood components, blood products, cells, tissues or organs that are intended for transfusion or transplantation, and they are not Class 4 IVDs under rule 1.2 (2). IHRs intended to detect red cell antigens other than those specified in rule 1.2 (2), and HLA antigens, are Class 3 IVDs. Sensitised cells and reagents used in compatibility tests are also Class 3 IVDs. The detection of biological markers is taken to include any genetic or molecular-based methodologies where the results of testing may be used to establish or confirm suitability for transfusion or transplantation.
Any IVDs, including all associated calibrator and control materials, that are intended to be used for the quantitative determination of maternal allo-antibodies directed towards red cell antigens, in order to detect or monitor haemolytic disease in an unborn child or newborn, are Class 3 IVDs under Rule 1.3 (e).
Classification rule 1.7 specifies that an IVD not otherwise classified under Schedule 2A is a Class 2 IVD or Class 2 in-house IVD. For example, the Kleihauer test used for the (semi-)quantitative determination of foetal red blood cells in maternal circulation. Note that Rule 1.3 (1) (f) for determining Class 3 IVDs is not considered to be applicable to the Kleihauer test.
Classification rule 1.6 specifies those IVDs and in-house IVDs that are Class 1. It includes:
- Instruments to be used for in vitro diagnostic procedures, e.g. automated blood grouping analysers;
- Instrument-specific reagents that are not also analyte-specific. Analyte-specific reagents are classified as the same class as the parent IVD they are intended to be used with.
- General laboratory reagents suitable for use across multiple disciplines, e.g. normal saline, provided there is no specific indication that the reagent is intended for use in immunohaematology or tissue typing.
- Specimen receptacles other than those intended for use in self-testing;
- IVDs intended only to be exported from Australia.
Laboratory reagents that state in their labelling or in their accompanying information that they are intended for use in immunohaematology or tissue typing are considered to be Class 3 or Class 4 IVDs, not Class 1 general laboratory reagents.