Cleared Traditional

URIC ACID COLORIMETRIC DETERMINATION (K830679) - FDA 510(k) Clearance

Class I Chemistry device.

K830679 · Dow Instruments & Reagents, Inc. · Chemistry device
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Apr 1983
Decision
33d
Days
Class 1
Risk

K830679 is an FDA 510(k) clearance for the URIC ACID COLORIMETRIC DETERMINATION. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Dow Instruments & Reagents, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 33 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 Dow Instruments & Reagents, Inc. devices

Submission Details

510(k) Number K830679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date April 06, 1983
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
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 40
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K830679.
SYSTEMATE URIC ACID, HEM 67220
K843325 · Em Diagnostic Systems, Inc. · Sep 1984
TDX REA URIC ACID
K841702 · Abbott Laboratories · May 1984
URIC ACID REAGENT
K840781 · American Dade · Apr 1984
BECKMAN URIC ACID REAGENT
K821812 · Beckman Instruments, Inc. · Jul 1982
URIC ACID SYSTEM PACK TEST
K812978 · Boehringer Mannheim Corp. · Nov 1981
LANCER URIC ACID AUTO/STAT KIT
K802692 · Sherwood Medical Co. · Dec 1980