Cleared Traditional

K943866 - VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS

K943866 is an FDA 510(k) clearance for VALPROIC ACID FPIA REAGENT SET AND CALI..., manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code LEG cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K943866 · Sigma Diagnostics, Inc. · Chemistry device
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Nov 1994
Decision
94d
Days
Class 2
Risk

K943866 is an FDA 510(k) clearance for the VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K943866

510(k) Number K943866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date November 10, 1994
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEG Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K943866.
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
AXSYM VALPROIC ACID
K941615 · Abbott Laboratories · Aug 1994
VALPROIC ACID
K936208 · Seradyn, Inc. · Mar 1994
BIOTRACK VALPROIC ACID TEST CARTRIDGE
K934061 · Biotrack, Inc. · Dec 1993