# K992422: Accusign DOA3,Doa, Coc/THC/OPI2000 DOA3; Biosign DOA3, Coc/THC/OPI2000; Status DS Coc/THC/OPI2000

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Aug 10, 1999 after 20 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 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 abuse samples. The detection cut-off concentrations are as follows: MET d-Methamphetamine 1000 ng/mL OPI Morphine 2000 ng/mL COC 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 1000 ng/mL 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 of abuse samples. Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), phencyclidine and/or their metabolites in human urine to assist in screening of drug of abuse samples. Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), and/or their metabolites in human urine to assist in screening of drug of abuse samples. Immunoassay for the qualitative detection of THC, opiates, cocaine, and/or their metabolites in human urine to assist in screening of drug of abuse samples. Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, cocaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows: THC 11-nor-A%-9-carboxylic acid 50 ng/mL OPI Morphine 2000 ng/mL COC Benzoylecgonine 300 ng/mL AMP Amphetamine 1000 ng/mL MET D-Methamphetamine 1000 ng/mL PCP Phencyclidine 25 ng/mL

Source page: https://510kreport.com/device/K992422
Methodology: https://510kreport.com/methodology