# K981801: Accusign Tca, Biosign Tca, Staus DS Tca

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Aug 25, 1998 after 96 days
- Product code: LFH (U.V. Spectrometry, Tricyclic Antidepressant Drugs)
- Device class: 2
- Regulation: 21 CFR 862.3910
- 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 Tricyclic Antidepressants (Nortriptyline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.

Source page: https://510kreport.com/device/K981801
Methodology: https://510kreport.com/methodology