Cleared Special

K072714 - TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

K072714 is an FDA 510(k) clearance for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 206-day FDA review.

K072714 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
206d
Days
Class 2
Risk

K072714 is an FDA 510(k) clearance for the TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 18, 2008 after a review of 206 days - an extended review cycle.

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 - K072714

510(k) Number K072714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2007
Decision Date April 18, 2008
Days to Decision 206 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
118d slower than avg
Panel avg: 88d · This submission: 206d
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 235
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K072714.
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
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K080618 · Jas Diagnostics, Inc. · May 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
DCA VANTAGE, MODEL 5075
K071466 · Siemens Medical Solutions Diagnostics · Oct 2007
K072714 · TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
Download PDF FDA Summary Roche Diagnostics Cor…