# K980249: Accusign Tca, Biosign Tca, Staus DS Tca

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Mar 13, 1998 after 49 days
- Product code: LFG (Radioimmunoassay, 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.
93 later devices descend from it; 1 cites it directly.
0 of 94 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
- K021526: Acon Tca One Step Tricyclic Antidepressant Test Strip and Device (2002), 92 descendants of its own
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device (2003), 86 descendants of its own
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card (2003), 83 descendants of its own
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own

## Indications for use
Immunoassay for the qualitative detection of TCA 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/K980249
Methodology: https://510kreport.com/methodology