ASR products are “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.” (21 CFR 864.4020(a)).
ASRs are medical devices that are regulated by FDA.
Most of the ASRs are Class I and exempt from premarket notification. These products are subject to general controls, including current Good Manufacturing Practices (cGMPs) (21 CFR Part 820) as well as the specific provisions of the ASR regulations (21 CFR 809.10(e), 809.30, 864.4020).
There are some ASRs that are Class II and Class III and that must be cleared or approved by FDA before they can be marketed in the United States.
An ASR is a Class II device if the reagent is used as a component in a blood banking test of a type that has been classified as a Class II device (e.g., certain cytomegalovirus serological and treponema pallidum nontreponemal test reagents) (21 CFR 864.4020(b)(2)).
An ASR is a Class III device if the reagent is intended as a component in tests intended either:
• to diagnose a contagious condition that is highly likely to result in a fatal outcome and prompt, accurate diagnosis offers the opportunity to mitigate the public health impact of the condition (e.g., human immunodeficiency virus (HIV/AIDS) or tuberculosis (TB)); or
• for use in donor screening for conditions for which FDA has recommended or required testing in order to safeguard the blood supply or establish the safe use of blood and blood products (e.g., tests for hepatitis or for identifying blood groups) (21 CFR 864.4020(b)(3)). FDA considers ASRs intended to be used as a component in tests for diagnosis of HIV (including monitoring for viral load or HIV drug resistance mutations) to be Class III ASRs.
Class I ASR products shall bear the statement: “Analyte Specific Reagent. Analytical and performance characteristics are not established.”
Class II and III ASR products must bear the statement: “Analyte Specific Reagent. Except as a component of the approved/cleared test (Name of approved/cleared test), analytical and performance characteristics of this ASR are not established”.