Cleared Traditional

EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL (K002551) - FDA 510(k) Clearance

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

K002551 · Dade Behring, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2000
Decision
55d
Days
Class 2
Risk

K002551 is an FDA 510(k) clearance for the EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G0.... Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on October 11, 2000 after a review of 55 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K002551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 11, 2000
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 34
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K002551.
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co. · Jul 2001
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · Dade Behring, Inc. · Aug 1998
AXSYM VALPROIC ACID
K941615 · Abbott Laboratories · Aug 1994
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