Cleared Special

K151809 - Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

K151809 is an FDA 510(k) clearance for Alere Afinion HbA1c, manufactured by Alere Technologies AS. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 85-day FDA review.

K151809 · Alere Technologies AS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
85d
Days
Class 2
Risk

K151809 is an FDA 510(k) clearance for the Alere Afinion HbA1c, Alere Afinion AS100 Analyzer. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Alere Technologies AS (Oslo, NO). The FDA issued a Cleared decision on September 25, 2015 after a review of 85 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 Alere Technologies AS devices

FDA 510(k) Submission Details - K151809

510(k) Number K151809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2015
Decision Date September 25, 2015
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K151809.
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
K160762 · Diazyme Laboratories · Nov 2016
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HOME ACCESS AIC TEST
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K142789 · Sakae Corporation · Dec 2014
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K133803 · Diazyme Laboratories · Aug 2014