Cleared Traditional

K821945 - CARBAMAZEPINE FLOURESCENT IMMUNOASSAY

K821945 is the FDA 510(k) clearance for CARBAMAZEPINE FLOURESCENT IMMUNOASSAY by American Diagnostic Corp.. It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K821945 · American Diagnostic Corp. · Toxicology device
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Jul 1982
Decision
17d
Days
Class 2
Risk

K821945 is an FDA 510(k) clearance for the CARBAMAZEPINE FLOURESCENT IMMUNOASSAY. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1982 after a review of 17 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K821945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1982
Decision Date July 16, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K821945.
STRATUS CARBAMAZEPINE FLUROMETRIC
K832447 · American Dade · Sep 1983
A-GENT CARBAMAZEPINE
K832631 · Abbott Laboratories · Sep 1983
CARBAMEZEPINE REAGENT TEST KIT
K831222 · Beckman Instruments, Inc. · May 1983
CARBAMAZEPINE ASSAY
K820189 · Syva Co. · Feb 1982
AMES TDA CARBAMAZEPINE TEST
K811952 · Miles Laboratories, Inc. · Jul 1981
CYBREX CARBAMAZEPINE
K802902 · Abbott Laboratories · Dec 1980