# K014193: Lifesign Doa 4 (THC/Opi/Coc/Met)

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: May 23, 2002 after 153 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981771 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990786: Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp, Biosign DOA10, Biosign Met/Opi/, Princeton BioMeditech Corp. (1999) Summary page 1.
- K981771: Accusign Mop, Biosign Mop, Staus DS Mop, Princeton BioMeditech Corp. (1998) Summary page 1.

## Most influential descendants
- K023837: Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma (2003), 0 descendants of its own

## Indications for use
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine 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 ng/ml COC Benzoylecgonine 300 ng/ml MET D-Methamphetamine 1000 ng/ml Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine 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-A°>-THC-9-carboxylic acid 50 ng/ml OPI Morphine 2000 ng/ml COC Benzoylecgonine 300 ng/ml MET D-Methamphetamine 1000 ng/ml

Source page: https://510kreport.com/device/K014193
Methodology: https://510kreport.com/methodology