Cleared Traditional

IQ URIC ACID TEST (K864341) - FDA 510(k) Clearance

Class I Chemistry device.

K864341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Dec 1986
Decision
42d
Days
Class 1
Risk

K864341 is an FDA 510(k) clearance for the IQ URIC ACID TEST. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 42 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K864341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date December 16, 1986
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K864341.
URIC ACID PAP
K873363 · Boehringer Mannheim Corp. · Oct 1987
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER
K871892 · Technicon Instruments Corp. · Jun 1987
EASY-TEST URIC ACID (URIC) #16606
K870868 · Em Diagnostic Systems, Inc. · Mar 1987
REFLOTRON URIC ACID
K861831 · Boehringer Mannheim Corp. · Jul 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · Em Diagnostic Systems, Inc. · Apr 1986
URIC ACID REAGENT
K853357 · Sigma Diagnostics, Inc. · Aug 1985