# K974181: Accusign Doa 2, Accusign Doa, Accusign Bar/Bzo, Biosign Doa 2, Biosign Bar/Bzo, First Check Panel 2 Bar/Bzo, Status DS B

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Dec 11, 1997 after 35 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- 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 Barbiturates, Benzodiazephines and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.

Source page: https://510kreport.com/device/K974181
Methodology: https://510kreport.com/methodology