Cleared Traditional

EMIT METHATREXATE ASSAY (K781381) - FDA 510(k) Clearance

K781381 · Dade Behring, Inc. · Toxicology device
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Oct 1978
Decision
60d
Days
-
Risk

K781381 is an FDA 510(k) clearance for the EMIT METHATREXATE ASSAY. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K781381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1978
Decision Date October 10, 1978
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 87d · This submission: 60d
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 K781381.
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TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K932615 · Abbott Laboratories · Jul 1993
EMIT & METHOFREXATE ASSAY
K833634 · Syva Co. · Dec 1983
TDX METHOTREXATE
K830398 · Abbott Laboratories · Mar 1983
EMIT-AND METHOTREXATE ASSAY
K811459 · Syva Co. · Jun 1981