Cleared Traditional

AXIOM STABLE II URIC ACID TEST (K842442) - FDA 510(k) Clearance

Class I Chemistry device.

K842442 · Axiom, Inc. · Chemistry device
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Aug 1984
Decision
56d
Days
Class 1
Risk

K842442 is an FDA 510(k) clearance for the AXIOM STABLE II URIC ACID TEST. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Axiom, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1984 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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 Axiom, Inc. devices

Submission Details

510(k) Number K842442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1984
Decision Date August 16, 1984
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
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.

Regulatory Peers - KNK Acid, Uric, Uricase (colorimetric)

All 35
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K842442.
URIC ACID REAGENT
K853357 · Sigma Diagnostics, Inc. · Aug 1985
FOCUS URIC ACID
K844011 · Abbott Laboratories · Oct 1984
SYSTEMATE URIC ACID, HEM 67220
K843325 · Em Diagnostic Systems, Inc. · Sep 1984
TDX REA URIC ACID
K841702 · Abbott Laboratories · May 1984
BECKMAN URIC ACID REAGENT
K821812 · Beckman Instruments, Inc. · Jul 1982
URIC ACID SYSTEM PACK TEST
K812978 · Boehringer Mannheim Corp. · Nov 1981