Cleared Traditional

K110313 - TINA-QUANT HBA1C GEN.2

K110313 is the FDA 510(k) clearance for TINA-QUANT HBA1C GEN.2 by Roche Diagnostics. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K110313 · Roche Diagnostics · Chemistry device
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Dec 2011
Decision
324d
Days
Class 2
Risk

K110313 is an FDA 510(k) clearance for the TINA-QUANT HBA1C GEN.2. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 23, 2011 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K110313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2011
Decision Date December 23, 2011
Days to Decision 324 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
236d slower than avg
Panel avg: 88d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 111
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K110313.
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
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GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · Beckman Coulter, Inc. · Oct 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · Beckman Coulter, Inc. · Sep 2012
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · Siemens Healthcare Diagnostics · Aug 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · Siemens Healthcare Diagnostics · May 2011
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · Bio-Rad Laboratories, Inc. · Jul 2009