Cleared Traditional

K970919 - SYNCHRON CX SYSTEMS URIC ACID (URIC) RE...

K970919 is an FDA 510(k) clearance for SYNCHRON CX SYSTEMS URIC ACID (URIC) RE..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 70-day FDA review.

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

FDA 510(k) Submission Details - K970919

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.

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 K970919.
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · Clinical Data, Inc. · Jul 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022096 · Bayer Diagnostics Corp. · Mar 2003
WAKO L-TYPE UA F TEST
K993469 · Wako Chemicals USA, Inc. · Nov 1999
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