Cleared Traditional

K091884 - ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

K091884 is an FDA 510(k) clearance for ARK ZONISAMIDE ASSAY, manufactured by ARK Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code NWM cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K091884 · ARK Diagnostics, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Dec 2009
Decision
168d
Days
Class 2
Risk

K091884 is an FDA 510(k) clearance for the ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, M.... Classified as Immunoassay, Anti-seizure Drug (product code NWM), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 9, 2009 after a review of 168 days - an extended review cycle.

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

FDA 510(k) Submission Details - K091884

510(k) Number K091884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2009
Decision Date December 09, 2009
Days to Decision 168 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 87d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NWM Device Classification - Class 2, Special Controls

Product Code NWM Immunoassay, Anti-seizure Drug
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
Definition To Aid In Management Of Patients Treated With Anti-seizure Drug.
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.

Regulatory Peers - NWM Immunoassay, Anti-seizure Drug

Devices cleared under the same product code (NWM) and FDA review panel - the closest regulatory comparables to K091884.
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