Cleared Traditional

K830789 - AMES TDA VALPROIC ACID TEST

K830789 is the FDA 510(k) clearance for AMES TDA VALPROIC ACID TEST by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code LEG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830789 · Miles Laboratories, Inc. · Chemistry device
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Apr 1983
Decision
29d
Days
Class 2
Risk

K830789 is an FDA 510(k) clearance for the AMES TDA VALPROIC ACID TEST. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 29 days - a notably fast clearance cycle.

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: 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K830789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date April 12, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K830789.
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
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
K822933 · Syva Co. · Oct 1982
CYBREX VALPROIC ACID
K803236 · Abbott Laboratories · Jan 1981
EMIT VALPROIC ACID ASSAY
K801207 · Syva Co. · Jun 1980