Cleared Traditional

K002551 - EMIT 2000 VALPROIC ACID ASSAY

K002551 is the FDA 510(k) clearance for EMIT 2000 VALPROIC ACID ASSAY by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code LEG) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K002551 · Dade Behring, Inc. · Chemistry device
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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 26
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K002551.
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · Beckman Coulter, Inc. · Jul 2003
RANDOX VALPROIC ACID
K011649 · Randox Laboratories, Ltd. · Jan 2002
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co. · Jul 2001
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
K000005 · Diagnostic Products Corp. · Mar 2000
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · Dade Behring, Inc. · Aug 1998
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
K972132 · Sigma Diagnostics, Inc. · Jul 1997