# K014069: Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jun 10, 2002 after 182 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 K990786 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Immunoassay for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cut-off of 300 ngimL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use Immunoassay for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of drugs of abuse at home. For In vitro Diagnostic Use

Source page: https://510kreport.com/device/K014069
Methodology: https://510kreport.com/methodology