Cleared Special

K182988 - Afinion HbA1c Dx on Afinion 2 (FDA 510(k) Clearance)

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

K182988 · Alere Technologies AS · Chemistry device
Nov 2018
Decision
31d
Days
Class 2
Risk

K182988 is an FDA 510(k) clearance for the Afinion HbA1c Dx on Afinion 2. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Alere Technologies AS (Oslo, NO). The FDA issued a Cleared decision on November 29, 2018 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - 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 K182988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2018
Decision Date November 29, 2018
Days to Decision 31 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
203d faster than avg
Panel avg: 234d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
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 - PDJ Hemoglobin A1c Test System

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