Cleared Traditional

K930734 - CEDIA VALPORIC ACID ASSAY

K930734 is the FDA 510(k) clearance for CEDIA VALPORIC ACID ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code LEG) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K930734 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
222d
Days
Class 2
Risk

K930734 is an FDA 510(k) clearance for the CEDIA VALPORIC ACID ASSAY. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on September 21, 1993 after a review of 222 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corp. devices

Submission Details

510(k) Number K930734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date September 21, 1993
Days to Decision 222 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
135d slower than avg
Panel avg: 87d · This submission: 222d
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 K930734.
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
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
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · Pb Diagnostic Systems, Inc. · Jun 1990