Cleared Traditional

K780827 - URIC ACID RAPID STAT KIT

K780827 is an FDA 510(k) clearance for URIC ACID RAPID STAT KIT, manufactured by Pierce Chemical Co.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K780827 · Pierce Chemical Co. · Chemistry device
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Jun 1978
Decision
25d
Days
Class 1
Risk

K780827 is an FDA 510(k) clearance for the URIC ACID RAPID STAT KIT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Pierce Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1978 after a review of 25 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 Pierce Chemical Co. devices

FDA 510(k) Submission Details - K780827

510(k) Number K780827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1978
Decision Date June 13, 1978
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

KNK Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K780827.
FLOZYME* URIC ACID REAGENT
K790486 · Worthington Diagnostic Systems · Apr 1979
URIC ACID, BOUND ENZYME
K790092 · Technicon Instruments Corp. · Mar 1979
HMA URIC ACID TEST
K781004 · Hycel, Inc. · Jul 1978
UNIPAK URIC ACID
K771088 · Harleco · Jul 1977
URIC ACID TEST, BMC AUTOFLO
K770272 · Boehringer Mannheim Corp. · Mar 1977