Cleared Traditional

ONLINE TDM Methotrexate (K233454) - FDA 510(k) Clearance

K233454 · Roche Diagnostics Operations · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
123d
Days
-
Risk

K233454 is an FDA 510(k) clearance for the ONLINE TDM Methotrexate. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by Roche Diagnostics Operations (Indianapolis, US). The FDA issued a Cleared decision on February 20, 2024 after a review of 123 days - within the typical 510(k) review window.

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 K233454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2023
Decision Date February 20, 2024
Days to Decision 123 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
36d slower than avg
Panel avg: 87d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -

Regulatory Peers - LAO Enzyme Immunoassay, Methotrexate

All 9
Devices cleared under the same product code (LAO) and FDA review panel - the closest regulatory comparables to K233454.
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
EMIT-AND METHOTREXATE ASSAY
K811459 · Syva Co. · Jun 1981