Cleared Special

K052464 - TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

K052464 is the FDA 510(k) clearance for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code LCP) cleared through the Special 510(k) pathway after a 22-day FDA review.

K052464 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
22d
Days
Class 2
Risk

K052464 is an FDA 510(k) clearance for the TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST. 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 September 30, 2005 after a review of 22 days - a notably fast clearance 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. 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K052464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2005
Decision Date September 30, 2005
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 110
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K052464.
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · Ortho-Clinical Diagnostics, Inc. · Apr 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · Microgenics Corp. · Feb 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · Bio-Rad Laboratories, Inc. · Jan 2006
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · Beckman Coulter, Inc. · Nov 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · Bio-Rad Laboratories, Inc. · Jun 2004
VARIANT II HEMOGLOBIN A1C
K040872 · Bio-Rad Laboratories, Inc. · Apr 2004