Cleared Traditional

SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT (K970919) - FDA 510(k) Clearance

Class I Chemistry device.

K970919 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
70d
Days
Class 1
Risk

K970919 is an FDA 510(k) clearance for the SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 21, 1997 after a review of 70 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K970919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date May 21, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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 K970919.
URIC ACID MODEL 3P39
K102568 · Abbott Laboratories · May 2011
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862 · Olympus America, Inc. · Apr 2007
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · Eastman Kodak Company · Apr 1994
IL TEST URIC ACID
K931350 · Instrumentation Laboratory CO · Oct 1993
OLYMPUS URIC ACID REAGENT
K925113 · Olympus Corp. · Jan 1993
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · Heraeus Kulzer, Inc. · Sep 1992