# K142293: Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biophor Diagnostics, Inc.
- Decided: Sep 18, 2015 after 396 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 4.

## Indications for use
The RapidFRET Oral Fluid Assay for Methamphetamine is a homogencous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for methamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To oblain a confirmed analytical result. a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug Lest result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only. The RapidFRET Oral Fluid Methamphetamine Calibrators and RapidFRET Oral Fluid Methamphetamine Controls are intended for use only with appropriatc RapidFRET Oral Fluid Assay products and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutofT level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems. operators. precision. accuracy and assay conditions. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K142293
Methodology: https://510kreport.com/methodology