Cleared Traditional

UN(UREASE)REAGENT UN(A-KETO)REAGENT (K851991) - FDA 510(k) Clearance

Class I Chemistry device.

K851991 · Alpkem Corp. · Chemistry device

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May 1985

Decision

22d

Days

Class 1

Risk

K851991 is an FDA 510(k) clearance for the UN(UREASE)REAGENT UN(A-KETO)REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 22 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 Alpkem Corp. devices

Submission Details

510(k) Number	K851991 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 07, 1985
Decision Date	May 29, 1985
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

66d faster than avg

Panel avg: 88d · This submission: 22d

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 29

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K851991.

IQ URIC ACID TEST

K864341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986

REFLOTRON URIC ACID

K861831 · Boehringer Mannheim Corp. · Jul 1986

EASY-TEST URIC ACID (URIC), #67516/93

K860916 · Em Diagnostic Systems, Inc. · Apr 1986

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

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 K851991

Alpkem Corp.

Clackamas, OR · US

YOSIP F WARDA

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in Chemistry

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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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