Cleared Special

K151809 - Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151809 · Alere Technologies AS · Chemistry device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
149d faster than avg
Panel avg: 234d · This submission: 85d
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.