The FDA defines analyte specific reagents (ASRs) in 21 CFR 864.4020 as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended to use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.” In simple terms an analyte specific reagent is the active ingredient of an in-house test.
External links
- FDA Guidance for Industry - Analyte Specific Reagents (Small Entity Compliance Guidance), February 26, 2003
- Code of Federal Regulations - Specimen Preparation Reagents (21CFR864.4020)
