Cleared Traditional

K901538 - MODIFIED OPUS VALPROIC ACID TEST SYSTEM

K901538 is the FDA 510(k) clearance for MODIFIED OPUS VALPROIC ACID TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LEG) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K901538 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jun 1990
Decision
85d
Days
Class 2
Risk

K901538 is an FDA 510(k) clearance for the MODIFIED OPUS VALPROIC ACID TEST SYSTEM. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 85 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K901538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date June 26, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 87d · This submission: 85d
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 K901538.
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
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581 · Roche Diagnostic Systems, Inc. · Aug 1989
EMIT VALPROIC ACID ASSAY
K862652 · Syva Co. · Jul 1986
EMIT AED VALPROIC ACID ASSAY
K832719 · Syva Co. · Oct 1983