Cleared Traditional

URIC ACID SYSTEM PACK TEST (K812978) - FDA 510(k) Clearance

Class I Chemistry device.

K812978 · Boehringer Mannheim Corp. · Chemistry device

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Nov 1981

Decision

14d

Days

Class 1

Risk

K812978 is an FDA 510(k) clearance for the URIC ACID SYSTEM PACK TEST. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 14 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number	K812978 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 23, 1981
Decision Date	November 06, 1981
Days to Decision	14 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

74d faster than avg

Panel avg: 88d · This submission: 14d

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 39

Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K812978.

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

LANCER URIC ACID AUTO/STAT KIT

K802692 · Sherwood Medical Co. · Dec 1980

AMES SERA-PAK URIC ACID REAGENT KIT

K802724 · Miles Laboratories, Inc. · Dec 1980

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES

K801649 · Eastman Kodak Company · Aug 1980

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 K812978

Boehringer Mannheim Corp.

Mchenry, IL · US

Regulatory profile

340 submissions 340 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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