Cleared Traditional

K964765 - CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY

K964765 is an FDA 510(k) clearance for CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPI..., manufactured by Chiron Diagnostics Corp.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K964765 · Chiron Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
79d
Days
Class 2
Risk

K964765 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 79 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 Chiron Diagnostics Corp. devices

FDA 510(k) Submission Details - K964765

510(k) Number K964765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date February 14, 1997
Days to Decision 79 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
8d faster than avg
Panel avg: 87d · This submission: 79d
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
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