Cleared Traditional

URIC ACID TEST (K864119) - FDA 510(k) Clearance

Class I Chemistry device.

K864119 · U. S. Diagnostics, Inc. · Chemistry device
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Oct 1986
Decision
8d
Days
Class 1
Risk

K864119 is an FDA 510(k) clearance for the URIC ACID TEST. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on October 29, 1986 after a review of 8 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 U. S. Diagnostics, Inc. devices

Submission Details

510(k) Number K864119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date October 29, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 88d · This submission: 8d
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 117
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K864119.
URIC ACID MODEL 3P39
K102568 · Abbott Laboratories · May 2011
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954 · Abbott Laboratories · Feb 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · Baxter Healthcare Corp · Feb 1990
PARAMAX URIC ACID REAGENT
K873456 · Baxter Healthcare Corp · Nov 1987
IQ URIC ACID TEST
K864341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986
FOCUS URIC ACID
K844011 · Abbott Laboratories · Oct 1984