Cleared Traditional

K933684 - IL TEST CARBAMAZEPHINE

K933684 is the FDA 510(k) clearance for IL TEST CARBAMAZEPHINE by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K933684 · Instrumentation Laboratory CO · Toxicology device
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Oct 1993
Decision
64d
Days
Class 2
Risk

K933684 is an FDA 510(k) clearance for the IL TEST CARBAMAZEPHINE. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 64 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K933684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date October 01, 1993
Days to Decision 64 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
23d faster than avg
Panel avg: 87d · This submission: 64d
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 K933684.
CARBAMAZEPINE EIA TEST
K955100 · Diagnostic Reagents, Inc. · Dec 1995
IL TEST CARBAMAZEPINE, PN 181754-00
K942687 · Instrumentation Laboratory CO · Jan 1995
AXSYM CARBAMAZEPHINE
K935374 · Abbott Laboratories · Jun 1994
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441 · Roche Diagnostic Systems, Inc. · May 1993
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · Microgenics Corp. · Jan 1992
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · Syva Co. · Jul 1991