Cleared Special

ARK Methotrexate Assay (K163359) - 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 -

Regulatory Peers - LAO Enzyme Immunoassay, Methotrexate

All 8
Devices cleared under the same product code (LAO) and FDA review panel - the closest regulatory comparables to K163359.
ONLINE TDM Methotrexate
K233454 · Roche Diagnostics Operations · Feb 2024
ARK Methotrexate II Assay
K232017 · ARK Diagnostics, Inc. · Dec 2023
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K932615 · Abbott Laboratories · Jul 1993
ACA DU PONT METHOTREXATE (MTHO) METHOD
K884744 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1989
EMIT & METHOFREXATE ASSAY
K833634 · Syva Co. · Dec 1983
TDX METHOTREXATE
K830398 · Abbott Laboratories · Mar 1983