# K252520: SEFRIA™ Hydrocodone Oral Fluid

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Sep 11, 2025 after 31 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924446 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203564: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay, Immunalysis Corporation (2021) Summary page 6.

## Indications for use
The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid to be used with clinical analyzers. This assay is calibrated against hydrocodone. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K252520
Methodology: https://510kreport.com/methodology