Cleared Traditional

K961988 - VALPROIC ACID EIA TEST

K961988 is the FDA 510(k) clearance for VALPROIC ACID EIA TEST by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code LEG) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K961988 · Diagnostic Reagents, Inc. · Toxicology device
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Jul 1996
Decision
56d
Days
Class 2
Risk

K961988 is an FDA 510(k) clearance for the VALPROIC ACID EIA TEST. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 56 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K961988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1996
Decision Date July 16, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
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 Toxicology 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 K961988.
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 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964442 · Bayer Corp. · Dec 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
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866 · Sigma Diagnostics, Inc. · Nov 1994