# K014066: Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THC

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jun 10, 2002 after 182 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 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 THC metabolite, 11-nor-A9-THC-9-carboxylic acid, at the cut-off of 50 ng/rnL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use Immunoassay for the qualitative detection of THC metabolite, 11-nor-A9-THC-9-carboxylic acid, at the cut-off of 50 nglmL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use

Source page: https://510kreport.com/device/K014066
Methodology: https://510kreport.com/methodology