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TD Tricyclic Antidepressants (LFG)

by Abbott Laboratories 510(k)

Active United States

510(k) K853113

Overview

This device is a Tricyclic Antidepressant Drug used for therapeutic purposes, classified under the product code LFG. Tricyclic antidepressants are a class of medications primarily prescribed to treat major depressive disorder and certain anxiety disorders by modulating neurotransmitter activity in the brain.

The TD Tricyclic Antidepressants are supplied as a pharmaceutical formulation and are regulated under FDA 510(k) clearance (K853113) as a Class II device under special controls. Authorized for clinical toxicology applications, this product is intended for prescription use only and is not a medical device in the traditional sense but rather a drug submission under the FDA’s regulatory framework. No additional sterility, single-use, or MRI safety specifications are noted.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853113 Date12 Aug 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-0325-04 FDA Unclassified (pre-2012) initiated 17 Nov 2003

    Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

    • Terminated Z-0691-03 FDA Unclassified (pre-2012) initiated 11 Dec 2002 via K853113, on the same 510(k)

    Unexpected false positive TCA results

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

Full name
Td Tricyclic Antidepressants
510(k) Number
FDA Product Code
LFG
Device Class
Class II
Regulation
21 CFR Part 862.3910
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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