Cleared Traditional

LEUCINE AMINOPEPTIDASE REAGENT (K844965) - FDA 510(k) Clearance

Class I Chemistry device.

K844965 · Alladin Diagnostic, Inc. · Chemistry device
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Mar 1985
Decision
71d
Days
Class 1
Risk

K844965 is an FDA 510(k) clearance for the LEUCINE AMINOPEPTIDASE REAGENT. Classified as L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase (product code JGG), Class I - General Controls.

Submitted by Alladin Diagnostic, Inc. (Princeton, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1460 - the FDA in vitro diagnostics and chemistry framework. 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 Alladin Diagnostic, Inc. devices

Submission Details

510(k) Number K844965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1984
Decision Date March 05, 1985
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGG L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1460
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.