Cleared Special

K071466 - DCA VANTAGE, MODEL 5075

K071466 is an FDA 510(k) clearance for DCA VANTAGE, manufactured by Siemens Medical Solutions Diagnostics. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 133-day FDA review.

K071466 · Siemens Medical Solutions Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
133d
Days
Class 2
Risk

K071466 is an FDA 510(k) clearance for the DCA VANTAGE, MODEL 5075. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Siemens Medical Solutions Diagnostics (Norowood, US). The FDA issued a Cleared decision on October 9, 2007 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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. Standard predicate reliance. 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 - K071466

510(k) Number K071466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date October 09, 2007
Days to Decision 133 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
44d slower than avg
Panel avg: 89d · This submission: 133d
Pathway characteristics
Modification to existing cleared device.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 248
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K071466.
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp. · Apr 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · Axis-Shield Diagnostics, Ltd. · Mar 2008
PRIMUS A1CARE ASSAY
K062658 · Primus Corp. · Nov 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
K070819 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · Jun 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · Bio-Rad Laboratories, Inc. · May 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
K063306 · Alfa Wassermann, Inc. · Apr 2007
K071466 · DCA VANTAGE, MODEL 5075
Download PDF FDA Summary Siemens Medical Solut…