Cleared Traditional

ACA DU PONT METHOTREXATE (MTHO) METHOD (K884744) - FDA 510(k) Clearance

K884744 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Jan 1989
Decision
77d
Days
-
Risk

K884744 is an FDA 510(k) clearance for the ACA DU PONT METHOTREXATE (MTHO) METHOD. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 77 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K884744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date January 30, 1989
Days to Decision 77 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
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -

Regulatory Peers - LAO Enzyme Immunoassay, Methotrexate

All 9
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