# K991018: Accusign Bar, Biosign Bar, Status Bar

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Apr 15, 1999 after 20 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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 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 drug.

Source page: https://510kreport.com/device/K991018
Methodology: https://510kreport.com/methodology