Cleared Traditional

K964442 - VALPROIC ACID ASSAY FOR THE TECHNICON I...

K964442 is the FDA 510(k) clearance for VALPROIC ACID ASSAY FOR THE TECHNICON I... by Bayer Corp.. It is a Class 2 Chemistry device (product code LEG) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K964442 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
42d
Days
Class 2
Risk

K964442 is an FDA 510(k) clearance for the VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - the FDA in vitro diagnostics and chemistry 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

Submission Details

510(k) Number K964442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date December 18, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEG Enzyme Immunoassay, Valproic Acid
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 Chemistry devices follow this clearance model.

Regulatory Peers - LEG Enzyme Immunoassay, Valproic Acid

All 27
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K964442.
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
K000005 · Diagnostic Products Corp. · Mar 2000
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · Dade Behring, Inc. · Aug 1998
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
K972132 · Sigma Diagnostics, Inc. · Jul 1997
VALPROIC ACID EIA TEST
K961988 · Diagnostic Reagents, Inc. · Jul 1996
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
K961256 · Beckman Instruments, Inc. · May 1996
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
K953224 · Roche Diagnostic Systems, Inc. · Oct 1995