# K991078: Accusign DOA8, DOA8 Panel, THC/Opi/Coc/Amp/Bzo/Bar/Tca/PCP, Biosign DOA8, THC/Opi/Coc/Amp/Bzo/Bar/Tca/Pap, Status DS DO8

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Apr 15, 1999 after 20 days
- Product code: DKE (Reagents, Test, Tetrahydrocannabinol)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug abuse samples.

Source page: https://510kreport.com/device/K991078
Methodology: https://510kreport.com/methodology