# K990786: Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp, Biosign DOA10, Biosign Met/Opi/

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Mar 26, 1999 after 16 days
- Product code: LAG (High Pressure Liquid 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
No predicates in its family tree.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K014193: Lifesign Doa 4 (THC/Opi/Coc/Met) (2002), 1 descendant of its own
- K014192: Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met (2002), 1 descendant of its own
- K023837: Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma (2003), 0 descendants of its own
- K014067: Lifesign Cocaine, Marijuana (THC), Lifesign DOA2 (THC/Coc), Status Stik THC/Coc, Accusign Stik THC/Coc, Accustik THC/Coc (2002), 0 descendants of its own
- K014066: Lifesign THC, Status Stik THC, Accusign Stik THC, Lifesign Marijuana, Accustik THC (2002), 0 descendants of its own

## Indications for use
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of drugs of abusc samples. The detection cut-off concentrations are as follows: MET — d-Methamphetamine — 1000 ng/mL OPI — Morphine — 300 ng/mL COoC — Benzoylecgonine — 300 ng/mL THC — 11-nor-A’-9-carboxylic acid — 50 ng/mL PCP — Phencyclidine — 25 ng/mL Benzodiazepine — Oxazepam — 300 ng/mL Barbiturate — Secobarbital — 300 ng/mL Methadone — Methadone — 300 ng/mL TCA — Nortriptyline — 1000 ng/mL Amphetamine — d-Amphetamine

Source page: https://510kreport.com/device/K990786
Methodology: https://510kreport.com/methodology