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Afinion HbA1c Dx on Afinion 2

by Alere Technologies AS Norway(FDA 510(k) applicant) 510(k)

510(k) K182988 Product code PDJ

Overview

The Afinion HbA1c Dx on Afinion 2 is a Hemoglobin A1c Test System designed for the quantitative measurement of glycated hemoglobin in human whole blood samples. It is intended for professional use in clinical settings and processes test cartridges containing venous or capillary whole blood.

The device is supplied as a single-use system and is intended for use by healthcare professionals. It is regulated under FDA 510(k) clearance and is classified as a Class II medical device. The Afinion 2 Analyzer is a compact, point-of-care, multi-assay system designed for efficient and accurate HbA1c testing.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK182988 Date29 Nov 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2192-2020 FDA Class II initiated 23 Mar 2020

    The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
PDJ
Device Class
Class II
Regulation
21 CFR Part 862.1373
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Alere Technologies AS

Questions

  • What is the Afinion HbA1c Dx on Afinion 2 used for?

    The Afinion HbA1c Dx on Afinion 2 is designed for the quantitative measurement of glycated hemoglobin in human whole blood samples, intended for professional use in clinical settings to help monitor diabetes management.

  • How is the Afinion HbA1c Dx supplied and is it reusable?

    The device is supplied as a single-use system and is intended for use by healthcare professionals. It processes test cartridges containing venous or capillary whole blood and should not be reused for patient safety and accuracy reasons.

  • What is the regulatory classification of the Afinion HbA1c Dx on Afinion 2?

    The Afinion HbA1c Dx on Afinion 2 is regulated under FDA 510(k) clearance and is classified as a Class II medical device. It received FDA clearance on November 29, 2018, with the decision code SESE indicating substantial equivalence.

  • What type of analyzer is the Afinion HbA1c Dx on Afinion 2?

    The Afinion 2 Analyzer is a compact, point-of-care, multi-assay system designed for efficient and accurate HbA1c testing. It is specifically configured to work with the HbA1c Dx test cartridges for quantitative measurement of glycated hemoglobin.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K182988 24 fields · synced 6 Oct 2026