Cleared Traditional

K781004 - HMA URIC ACID TEST

K781004 is the FDA 510(k) clearance for HMA URIC ACID TEST by Hycel, Inc.. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K781004 · Hycel, Inc. · Chemistry device
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Jul 1978
Decision
41d
Days
Class 1
Risk

K781004 is an FDA 510(k) clearance for the HMA URIC ACID TEST. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 41 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 Hycel, Inc. devices

Submission Details

510(k) Number K781004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1978
Decision Date July 27, 1978
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 83
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K781004.
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · Miles Laboratories, Inc. · Apr 1980
URIC ACID REAGENT
K791754 · Gilford Diagnostics · Sep 1979
URIC ACID, BOUND ENZYME
K790092 · Technicon Instruments Corp. · Mar 1979
UNIPAK URIC ACID
K771088 · Harleco · Jul 1977
URIC ACID TEST, BMC AUTOFLO
K770272 · Boehringer Mannheim Corp. · Mar 1977