Cleared Traditional

K940374 - QMS CARBAMAZEPINE ASSAY

K940374 is an FDA 510(k) clearance for QMS CARBAMAZEPINE ASSAY, manufactured by Seradyn, Inc.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K940374 · Seradyn, Inc. · Toxicology device
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Jun 1994
Decision
127d
Days
Class 2
Risk

K940374 is an FDA 510(k) clearance for the QMS CARBAMAZEPINE ASSAY. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 127 days - within the typical 510(k) review window.

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 Seradyn, Inc. devices

FDA 510(k) Submission Details - K940374

510(k) Number K940374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date June 02, 1994
Days to Decision 127 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
40d slower than avg
Panel avg: 87d · This submission: 127d
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 51
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K940374.
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
IL TEST CARBAMAZEPHINE
K933684 · Instrumentation Laboratory CO · Oct 1993
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