Cleared Special

K121366 - HEMOCUE HBA1C 501

K121366 is the FDA 510(k) clearance for HEMOCUE HBA1C 501 by Infopia Co, Ltd.. It is a Class 2 Chemistry device (product code LCP) cleared through the Special 510(k) pathway after a 123-day FDA review.

K121366 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2012
Decision
123d
Days
Class 2
Risk

K121366 is an FDA 510(k) clearance for the HEMOCUE HBA1C 501. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 7, 2012 after a review of 123 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.

View all Infopia Co, Ltd. devices

Submission Details

510(k) Number K121366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2012
Decision Date September 07, 2012
Days to Decision 123 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
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 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K121366.
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199 · Beckman Coulter, Inc. · Oct 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · Beckman Coulter, Inc. · Sep 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497 · Medica Corp. · May 2012
TINA-QUANT HBA1C GEN.2
K110313 · Roche Diagnostics · Dec 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · Siemens Healthcare Diagnostics · Aug 2011