Cleared Special

K011465 - SYNCHRON CX PRO CLINICAL SYSTEMS

K011465 is the FDA 510(k) clearance for SYNCHRON CX PRO CLINICAL SYSTEMS by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code LDP) cleared through the Special 510(k) pathway after a 25-day FDA review.

K011465 · Beckman Coulter, Inc. · Chemistry device
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Jun 2001
Decision
25d
Days
Class 2
Risk

K011465 is an FDA 510(k) clearance for the SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 8, 2001 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3030 - 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.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K011465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date June 08, 2001
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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 - LDP Colorimetry, Acetaminophen

All 27
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K011465.
TRIAGE TOX DRUG SCREEN
K043242 · Biosite Incorporated · Feb 2005
ACETAMINOPHEN-SL ASSAY
K042330 · Diagnostic Chemicals , Ltd. · Jan 2005
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp. · Jan 2002
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · Beckman Coulter, Inc. · Apr 2000
COBAS INTEGRA ACETAMINOPHEN
K991598 · Roche Diagnostics Corp. · Jul 1999