Cleared Traditional

K953761 - AXSYM TRICYCLIC ANTIDEPRESSANTS

K953761 is an FDA 510(k) clearance for AXSYM TRICYCLIC ANTIDEPRESSANTS, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LFH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K953761 · Abbott Laboratories · Toxicology device
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Nov 1995
Decision
103d
Days
Class 2
Risk

K953761 is an FDA 510(k) clearance for the AXSYM TRICYCLIC ANTIDEPRESSANTS. Classified as U.v. Spectrometry, Tricyclic Antidepressant Drugs (product code LFH), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3910 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K953761

510(k) Number K953761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1995
Decision Date November 22, 1995
Days to Decision 103 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 87d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFH Device Classification - Class 2, Special Controls

Product Code LFH U.v. Spectrometry, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.