Cleared Traditional

K832631 - A-GENT CARBAMAZEPINE

K832631 is an FDA 510(k) clearance for A-GENT CARBAMAZEPINE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K832631 · Abbott Laboratories · Toxicology device
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Sep 1983
Decision
39d
Days
Class 2
Risk

K832631 is an FDA 510(k) clearance for the A-GENT CARBAMAZEPINE. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K832631

510(k) Number K832631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date September 12, 1983
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 87d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 46
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K832631.
EMIT AED CARBAMAZEPINE ASSAY
K832720 · Syva Co. · Oct 1983
AMES TDA DISOPYRAMIDE TEST
K832766 · Miles Laboratories, Inc. · Sep 1983
STRATUS CARBAMAZEPINE FLUROMETRIC
K832447 · American Dade · Sep 1983
CARBAMEZEPINE REAGENT TEST KIT
K831222 · Beckman Instruments, Inc. · May 1983
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
K821945 · American Diagnostic Corp. · Jul 1982
CARBAMAZEPINE ASSAY
K820189 · Syva Co. · Feb 1982