Cleared Traditional

K936208 - VALPROIC ACID

K936208 is the FDA 510(k) clearance for VALPROIC ACID by Seradyn, Inc.. It is a Class 2 Chemistry device (product code LEG) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K936208 · Seradyn, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
72d
Days
Class 2
Risk

K936208 is an FDA 510(k) clearance for the VALPROIC ACID. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 72 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 Seradyn, Inc. devices

Submission Details

510(k) Number K936208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date March 11, 1994
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 28
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K936208.
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
AXSYM VALPROIC ACID
K941615 · Abbott Laboratories · Aug 1994
CEDIA VALPORIC ACID ASSAY
K930734 · Microgenics Corp. · Sep 1993
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · Roche Diagnostic Systems, Inc. · Dec 1992
BECKMAN VALPROIC ACID REAGENT
K922844 · Beckman Instruments, Inc. · Oct 1992