Cleared Traditional

AXSYM CARBAMAZEPHINE (K935374) - FDA 510(k) Clearance

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

K935374 · Abbott Laboratories · Toxicology device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
225d
Days
Class 2
Risk

K935374 is an FDA 510(k) clearance for the AXSYM CARBAMAZEPHINE. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 225 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 Abbott Laboratories devices

Submission Details

510(k) Number K935374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date June 21, 1994
Days to Decision 225 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
138d slower than avg
Panel avg: 87d · This submission: 225d
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 33
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K935374.
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · Beckman Instruments, Inc. · Feb 1997
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644 · Beckman Instruments, Inc. · Feb 1996
IL TEST CARBAMAZEPINE, PN 181754-00
K942687 · Instrumentation Laboratory CO · Jan 1995
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
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · Syva Co. · Jul 1991