# K983501: Accusign Doa 10,Accusign Doa Panel,Accusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp,Biosign Doa 10, Biosign Met/Opi/Coc/

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Dec 18, 1998 after 73 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K062575: Modification to: Accusign RC Doa 10 (Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp (2007), 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 screening of drug of abuse samples. The detecting cut-oft concentrations are as follows: MET D-Methamphetamine 1000 ng/mL OPI Morphine 300 ng/mL CcOoC 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

Source page: https://510kreport.com/device/K983501
Methodology: https://510kreport.com/methodology