Cleared Special

K071280 - SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

K071280 is an FDA 510(k) clearance for SYNCHRON CX DELTA CLINICAL SYSTEMS, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Special 510(k) pathway after a 25-day FDA review.

K071280 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
25d
Days
Class 2
Risk

K071280 is an FDA 510(k) clearance for the SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 1, 2007 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071280

510(k) Number K071280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2007
Decision Date June 01, 2007
Days to Decision 25 days
Submission Type Special
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
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 157
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K071280.
CREATININE
K083809 · Abbott Laboratories · Apr 2009
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
K072115 · Horiba Abx · Nov 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071277 · Beckman Coulter, Inc. · Jun 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · Beckman Coulter, Inc. · Jun 2007
CREATININE
K061193 · Abbott Laboratories, Inc. · Jun 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935 · Beckman Coulter, Inc. · Apr 2006
K071280 · SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Download PDF FDA Summary Beckman Coulter, Inc.