Cleared Traditional

K101574 - ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 (FDA 510(k) Clearance)

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

K101574 · ARK Diagnostics, Inc. · Toxicology device
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Nov 2010
Decision
169d
Days
Class 2
Risk

K101574 is an FDA 510(k) clearance for the ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL M.... Classified as Gabapentin Assay (product code OTF), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 169 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

Submission Details

510(k) Number K101574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2010
Decision Date November 23, 2010
Days to Decision 169 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
82d slower than avg
Panel avg: 87d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OTF Gabapentin Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
Definition Test For The Quantitative Determination Of Gabapentin In Human Serum Or Plasma. Gabapentin Concentrations Can Be Used As An Aid In Management Of Patients Treated With Gabapentin.
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.