Cleared Traditional

K232017 - ARK Methotrexate II Assay (FDA 510(k) Clearance)

K232017 · ARK Diagnostics, Inc. · Toxicology device
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Dec 2023
Decision
166d
Days
-
Risk

K232017 is an FDA 510(k) clearance for the ARK Methotrexate II Assay. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on December 20, 2023 after a review of 166 days - an extended review cycle.

This device falls under the Toxicology FDA review panel. 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.

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Submission Details

510(k) Number K232017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date December 20, 2023
Days to Decision 166 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
79d slower than avg
Panel avg: 87d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -