Cleared Traditional

K842246 - URIC ACID ASSAY KIT

K842246 is the FDA 510(k) clearance for URIC ACID ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K842246 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jul 1984
Decision
43d
Days
Class 1
Risk

K842246 is an FDA 510(k) clearance for the URIC ACID ASSAY KIT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 43 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K842246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date July 18, 1984
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K842246.
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
URIC ACID REAGENT SET ENZYMATIC
K841049 · Medical Specialties, Inc. · May 1984
URIC ACID REAGENT
K840781 · American Dade · Apr 1984