Cleared Special

K163359 - ARK Methotrexate Assay (FDA 510(k) Clearance)

K163359 · ARK Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
261d
Days
-
Risk

K163359 is an FDA 510(k) clearance for the ARK Methotrexate Assay. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 261 days - an extended review cycle.

This device falls under the Toxicology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ARK Diagnostics, Inc. devices

Submission Details

510(k) Number K163359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date August 18, 2017
Days to Decision 261 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 87d · This submission: 261d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -