Cleared Traditional

K830398 - TDX METHOTREXATE (FDA 510(k) Clearance)

K830398 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
31d
Days
-
Risk

K830398 is an FDA 510(k) clearance for the TDX METHOTREXATE. Classified as Enzyme Immunoassay, Methotrexate (product code LAO).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 10, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 Abbott Laboratories devices

Submission Details

510(k) Number K830398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1983
Decision Date March 10, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAO Enzyme Immunoassay, Methotrexate
Device Class -