Cleared Traditional

K943002 - URIC ACID QVET

K943002 is an FDA 510(k) clearance for URIC ACID QVET, manufactured by Prisma Systems. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K943002 · Prisma Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
162d
Days
Class 1
Risk

K943002 is an FDA 510(k) clearance for the URIC ACID QVET. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 162 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 Prisma Systems devices

FDA 510(k) Submission Details - K943002

510(k) Number K943002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 02, 1994
Days to Decision 162 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
74d slower than avg
Panel avg: 88d · This submission: 162d
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 83
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K943002.
URIC ACID (LIQUID) REAGENT SET
K970560 · Pointe Scientific, Inc., · Mar 1997
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586 · Diagnostic Chemicals , Ltd. · Jul 1996
URIC ACID CATALOGE# 220-93/94/97
K955496 · Diagnostic Chemicals , Ltd. · Feb 1996
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · Eastman Kodak Company · Apr 1994
IL TEST URIC ACID
K931350 · Instrumentation Laboratory CO · Oct 1993
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503 · Randox Laboratories, Ltd. · Jul 1993