Cleared Traditional

K090358 - ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

K090358 is an FDA 510(k) clearance for ARCHITECT IVALPROIC ACID REAGENTS AND A..., manufactured by Abbott Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LEG cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K090358 · Abbott Laboratories, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
175d
Days
Class 2
Risk

K090358 is an FDA 510(k) clearance for the ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, M.... Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Abbott Laboratories, Inc. (Abbott Park, US). The FDA issued a Cleared decision on August 6, 2009 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories, Inc. devices

FDA 510(k) Submission Details - K090358

510(k) Number K090358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2009
Decision Date August 06, 2009
Days to Decision 175 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
87d slower than avg
Panel avg: 88d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEG Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K090358.
ONLINE VALPROIC ACID
K060690 · Roche Diagnostics Corp. · Aug 2006
ADVIA IMS VALPROIC ACID METHOD
K042807 · Bayer Healthcare, LLC · Feb 2005
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476 · Ortho-Clinical Diagnostics, Inc. · Dec 2004
ROCHE ONLINE TDM VALPROIC ACID
K032049 · Roche Diagnostics Corp. · Aug 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · Beckman Coulter, Inc. · Jul 2003
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
K030405 · Seradyn · Apr 2003