Cleared Traditional

K932615 - TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (FDA 510(k) Clearance)

K932615 · Abbott Laboratories · Toxicology device
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Jul 1993
Decision
43d
Days
-
Risk

K932615 is an FDA 510(k) clearance for the TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 14, 1993 after a review of 43 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.

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Submission Details

510(k) Number K932615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1993
Decision Date July 14, 1993
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 87d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -