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510(k) K182988

Afinion HbA1c Dx on Afinion 2 by Alere Technologies AS — Product Code PDJ

K182988 is an FDA 510(k) premarket notification submitted by Alere Technologies AS for the device "Afinion HbA1c Dx on Afinion 2". The FDA issued a decision of Substantially Equivalent on November 29, 2018. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Alere Technologies AS has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2018
Date Received
October 29, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

Other clearances by Alere Technologies AS

  • K180296 — Afinion HbA1c Dx (May 7, 2018)
  • K151809 — Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (September 25, 2015)

Other clearances for product code PDJ

  • K252749 — Medconn 8K Glycated Hemoglobin Test System (January 6, 2026)
  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K242911 — Medconn Glycated Hemoglobin Test system (June 20, 2025)
  • K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System (September 12, 2024)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (July 2, 2021)
  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K182651 — HbA1c Advanced (January 16, 2019)
  • K173909 — Dimension Hemoglobin A1c Assay (July 13, 2018)
  • K173206 — SEKURE HbA1c Assay (July 12, 2018)

FDA data resources