# K853113: TD Tricyclic Antidepressants

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 12, 1985 after 19 days
- Product code: LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs)
- Device class: 2
- Regulation: 21 CFR 862.3910
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 17, 2003 · Not classified · Z-0325-04: Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
- Dec 11, 2002 · Not classified · Z-0691-03: Unexpected false positive TCA results

Source page: https://510kreport.com/device/K853113
Methodology: https://510kreport.com/methodology