Cleared Traditional

K943866 - VALPROIC ACID FPIA REAGENT SET AND CALI...

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

K943866 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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
CEDIA VALPORIC ACID ASSAY
K930734 · Microgenics Corp. · Sep 1993
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · Roche Diagnostic Systems, Inc. · Dec 1992