Cleared Traditional

K802902 - CYBREX CARBAMAZEPINE

K802902 is an FDA 510(k) clearance for CYBREX CARBAMAZEPINE, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code KLT cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K802902 · Abbott Laboratories · Immunology device
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Dec 1980
Decision
32d
Days
Class 2
Risk

K802902 is an FDA 510(k) clearance for the CYBREX 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 December 19, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3645 - the FDA immunology 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 - K802902

510(k) Number K802902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date December 19, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 104d · This submission: 32d
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 Immunology 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 K802902.
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
K821945 · American Diagnostic Corp. · Jul 1982
CARBAMAZEPINE ASSAY
K820189 · Syva Co. · Feb 1982
AMES TDA CARBAMAZEPINE TEST
K811952 · Miles Laboratories, Inc. · Jul 1981
EMIT AED ASSAYS 3500 COMPUTER DIRECTED
K790255 · Syva Co. · Mar 1979
ANALYTICAL TEST PACK, CARBAMAZEPINE
K781958 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1979
EMIT CARBAMAZEPINE ASSAY
K780466 · Syva Co. · Apr 1978