Cleared Special

K102914 - TQ HBA1C GEN3

K102914 is an FDA 510(k) clearance for TQ HBA1C GEN3, manufactured by Roche. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 111-day FDA review.

K102914 · Roche · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
111d
Days
Class 2
Risk

K102914 is an FDA 510(k) clearance for the TQ HBA1C GEN3. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Roche (Indianapolis, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 111 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 - K102914

510(k) Number K102914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date January 20, 2011
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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 241
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K102914.
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · Siemens Healthcare Diagnostics · May 2011
AFINION ANALYZER
K110056 · Axis-Shield Poc AS · Feb 2011
DIMENSION VISA HBA1C, MODEL K3105A
K102045 · Siemens Heatlhcare Diagnostics, Inc. · Feb 2011
ST AIA PACK HBA1C
K100304 · Tosoh Bioscience, Inc. · Aug 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
K082275 · Infopia Co, Ltd. · Jan 2010
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · Dec 2009
K102914 · TQ HBA1C GEN3
Download PDF FDA Summary Roche