Cleared Traditional

IL TEST URIC ACID (K931350) - FDA 510(k) Clearance

Class I Chemistry device.

K931350 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
198d
Days
Class 1
Risk

K931350 is an FDA 510(k) clearance for the IL TEST URIC ACID. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K931350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date October 01, 1993
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 88d · This submission: 198d
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 K931350.
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
IQ URIC ACID TEST
K864341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986
FOCUS URIC ACID
K844011 · Abbott Laboratories · Oct 1984
TDX REA URIC ACID
K841702 · Abbott Laboratories · May 1984