# K203647: SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Dec 22, 2021 after 373 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924446 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131652: Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls, Lin-Zhi International, Inc. (2014) Summary page 5.

## Indications for use
For In Vitro Diagnostic Use. The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 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 methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine. 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 Methamphetamine 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. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. 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/K203647
Methodology: https://510kreport.com/methodology