The laboratory purchases reagents from a manufacturer and develops an assay using standard references. What FDA category is this assay?

The correct answer is that the assay falls under the "analyte-specific reagent" category. This classification is applied when a laboratory develops an assay utilizing reagents manufactured for that specific purpose. Analyte-specific reagents are defined as those intended for use in detecting or measuring a particular analyte, which typically includes components like antibodies or nucleic acids for specific biomarkers.

In this case, the laboratory is using reagents purchased from a manufacturer and standard references to create an assay. Such development implies that the reagents are being used specifically for testing a defined analyte rather than as part of a manufactured kit or device that has gone through the full regulatory clearance processes.

This distinguishes the assay from the cleared category, which refers to tests that have undergone the FDA's 510(k) premarket notification process, demonstrating that they are substantially equivalent to an existing FDA-cleared assay.

Home-brew assays, on the other hand, are typically referred to tests developed and used entirely within a laboratory setting, without the use of specific analytes or commercial reagents meant for that purpose.

Lastly, "research use only" indicates reagents or assays that are not intended for diagnostic use, further differentiating from the context of this question where the laboratory is