# K021526: Acon Tca One Step Tricyclic Antidepressant Test Strip and Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jul 17, 2002 after 68 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
Longest line of descent: 1 generation back to K980249 (1998). 1 ancestor in all.
92 later devices descend from it; 5 cite 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)
- K980249: Accusign Tca, Biosign Tca, Staus DS Tca, Princeton BioMeditech Corp. (1998) Summary page 2.

## Most influential descendants
- 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
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own

## Indications for use
The ACON TCA One Step Tricyclic Antidepressants Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are rapid chromatographic immunoassays for the qualitative detection of Tricyclic Antidepressants in human urine at a cut-off concentration of 1,000 ng/mL in reference to Nortriptyline. They are intended for Healthcare professionals including professionals at the point-of-care sites.

Source page: https://510kreport.com/device/K021526
Methodology: https://510kreport.com/methodology