Cleared Traditional

IL TEST CARBAMAZEPINE, PN 181754-00 (K942687) - FDA 510(k) Clearance

Also marketed or referenced as:
IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942687 · Instrumentation Laboratory CO · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
232d
Days
Class 2
Risk

K942687 is an FDA 510(k) clearance for the IL TEST CARBAMAZEPINE, PN 181754-00. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 25, 1995 after a review of 232 days - an extended review 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: 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.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K942687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date January 25, 1995
Days to Decision 232 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 87d · This submission: 232d
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 55
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K942687.
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · Abbott Laboratories · Oct 2011
AXSYM CARBAMAZEPHINE
K935374 · Abbott Laboratories · Jun 1994
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
K834052 · Abbott Laboratories · Jan 1984
A-GENT CARBAMAZEPINE
K832631 · Abbott Laboratories · Sep 1983
CYBREX CARBAMAZEPINE
K802902 · Abbott Laboratories · Dec 1980