# K080455: Rapidsense  Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050

- Pathway: 510(k) (Traditional)
- Applicant: Quantrx Biomedical Corporation
- Decided: Dec 31, 2008 after 315 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: 2 generations back to K961249 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011672: Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device, ACON Laboratories, Inc. (2001) Summary page 2.

## Indications for use
The RapidSense TM Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methamphetamine and cause false positive results.

Source page: https://510kreport.com/device/K080455
Methodology: https://510kreport.com/methodology