Cleared Traditional

EMIT VALPROIC ACID ASSAY (K862652) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862652 · Syva Co. · Toxicology device
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Jul 1986
Decision
18d
Days
Class 2
Risk

K862652 is an FDA 510(k) clearance for the EMIT VALPROIC ACID ASSAY. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 29, 1986 after a review of 18 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 Syva Co. devices

Submission Details

510(k) Number K862652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1986
Decision Date July 29, 1986
Days to Decision 18 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
69d faster than avg
Panel avg: 87d · This submission: 18d
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 34
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K862652.
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co. · Jul 2001
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
K002551 · Dade Behring, Inc. · Oct 2000
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · Dade Behring, Inc. · Aug 1998
AXSYM VALPROIC ACID
K941615 · Abbott Laboratories · Aug 1994
EMIT AED VALPROIC ACID ASSAY
K832719 · Syva Co. · Oct 1983
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
K822933 · Syva Co. · Oct 1982