Cleared Traditional

K091653 - ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 (FDA 510(k) Clearance)

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

K091653 · ARK Diagnostics, Inc. · Toxicology device
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Nov 2009
Decision
146d
Days
Class 2
Risk

K091653 is an FDA 510(k) clearance for the ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM C.... Classified as Levetiracetam Assay (product code ORI), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 2, 2009 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all ARK Diagnostics, Inc. devices

Submission Details

510(k) Number K091653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date November 02, 2009
Days to Decision 146 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 87d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORI Levetiracetam Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
Definition For The Quantitative Determination Of Levetiracetam In Human Serum Or Plasma.
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.