Cleared Traditional

K940374 - QMS CARBAMAZEPINE ASSAY

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

K940374 · Seradyn, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 42
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