Cleared Traditional

K853825 - URIC ACID(URICASE) FOR CONTINUOUS FLOW ...

K853825 is the FDA 510(k) clearance for URIC ACID(URICASE) FOR CONTINUOUS FLOW ... by Catachem, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K853825 · Catachem, Inc. · Chemistry device
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Sep 1985
Decision
17d
Days
Class 1
Risk

K853825 is an FDA 510(k) clearance for the URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on September 30, 1985 after a review of 17 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 Catachem, Inc. devices

Submission Details

510(k) Number K853825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1985
Decision Date September 30, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 79
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K853825.
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · Em Diagnostic Systems, Inc. · Apr 1986
URIC ACID REAGNET SET (TRINDER)
K860477 · Sterling Diagnostics, Inc. · Apr 1986
IN-VITRO TEST DETERMINATION OF URIC ACID
K854185 · Clinical Data, Inc. · Nov 1985
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