Cleared Traditional

K964068 - CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

K964068 is an FDA 510(k) clearance for CARBAMAZEPINE ASSAY FOR THE TECHNICON I..., manufactured by Bayer Corp.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K964068 · Bayer Corp. · Toxicology device
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Dec 1996
Decision
64d
Days
Class 2
Risk

K964068 is an FDA 510(k) clearance for the CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 13, 1996 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 Bayer Corp. devices

FDA 510(k) Submission Details - K964068

510(k) Number K964068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1996
Decision Date December 13, 1996
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.

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 K964068.
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · Schiapparelli Biosystems, Inc. · Oct 1997
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K964765 · Chiron Diagnostics Corp. · Feb 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · Beckman Instruments, Inc. · Feb 1997
CARBAMAZEPINE FLEX REAGENT CARTRIDGE
K962820 · Dade Intl., Inc. · Sep 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644 · Beckman Instruments, Inc. · Feb 1996
CARBAMAZEPINE EIA TEST
K955100 · Diagnostic Reagents, Inc. · Dec 1995