# K023837: Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Sep 15, 2003 after 301 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 K981771 (1998). 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)
- K014193: Lifesign Doa 4 (THC/Opi/Coc/Met), Princeton BioMeditech Corp. (2002) Summary page 1.
- K014192: Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met, Princeton BioMeditech Corp. (2002) Summary page 5.

## Cited in the summary but kept off the family tree
- K014092: Status Stik MET. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Indications for use
Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GCMS is the preferred confirmatory method. Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use The detection cutoff concentrations are as follows: THC 11-nor-A'-THC-9-carboxylic acid 50 ng/ mL OPI Morphine 2000 ngl mL COC Benzoylecgonine 300 ngl mL MET D-Methamphetamine 500 ngl mL MDMA 3,4-Methylenedioxymethamphetamine 500 ngl mL This test provides only-.a preliminary analytical result and a more specific alternative chemical method must be used tc; obtain a confirmed analytical result and that GUMS is the preferred confirmatory method. Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GCMS is the preferred confirmatmy method. Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse samples at home or work places. For in vitro Diagnostic Use. The detection cutoff concentrations are as follows: THC 11-nor-A9-THC-9-carboxylicacid 50 ng/ mL OP I Morphine 2000 ng/ mL COC Benzoylecgonine 300 ng/ mL MET D-Methamphetamine 500 ng/ mL MDMA 3,4-methylenedioxymethamphetamine 500 ng/mL This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GUMS is the preferred confirmatory method.

Source page: https://510kreport.com/device/K023837
Methodology: https://510kreport.com/methodology