Cleared Traditional

K853357 - URIC ACID REAGENT

K853357 is the FDA 510(k) clearance for URIC ACID REAGENT by Sigma Diagnostics, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K853357 · Sigma Diagnostics, Inc. · Chemistry device

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Aug 1985

Decision

Days

Class 1

Risk

K853357 is an FDA 510(k) clearance for the URIC ACID REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 7 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number	K853357 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 1985
Decision Date	August 19, 1985
Days to Decision	7 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

81d faster than avg

Panel avg: 88d · This submission: 7d

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 78

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K853357.

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(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS

K853825 · Catachem, Inc. · Sep 1985

FOCUS URIC ACID

K844011 · Abbott Laboratories · Oct 1984

SYSTEMATE URIC ACID, HEM 67220

K843325 · Em Diagnostic Systems, Inc. · Sep 1984

URIC ACID ASSAY KIT

K842246 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K853357

Sigma Diagnostics, Inc.

St. Louis, MO · US

MATHEW MADAPPALLY

Regulatory profile

164 submissions 164 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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