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Axsym Tricyclic Antidepressants

by Abbott Laboratories 510(k)

Active United States

510(k) K953761

Overview

The device is a U.V. spectrometry system for tricyclic antidepressant drugs, classified under product code LFH and regulation number 862.3910. It is intended for use in clinical toxicology to detect and quantify tricyclic antidepressant compounds in biological specimens.

The device is supplied as a reusable in vitro diagnostic instrument, cleared by the FDA through the traditional 510(k) pathway under K953761 on November 22, 1995. It is manufactured by Abbott Laboratories and classified as a Class 2 medical device with no stated requirements for sterility, single-use designation, MRI safety, or specific storage conditions beyond standard laboratory use.

AI-generated from registry data, 26 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 NumberK953761 Date22 Nov 1995ClearedStatusActive

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-0323-04 FDA Unclassified (pre-2012) initiated 17 Nov 2003 via K953761, on the same 510(k)

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

    • Terminated Z-0689-03 FDA Unclassified (pre-2012) initiated 11 Dec 2002 via K953761, 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)

510(k) Number
FDA Product Code
LFH
Device Class
Class II
Regulation
21 CFR Part 862.3910
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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