Alere Afinion HbA1c and ACR on Afinion 2 analyzer— 510(k) K171650

Name: FDA 510(k) clearance K171650
Creator: U.S. Food and Drug Administration
Published: 2017-11-21

Substantially Equivalent

Abbott Rapid Diagnostics

FDA 510(k) clearance K171650 for Alere Afinion HbA1c and ACR on Afinion 2 analyzer, Substantially Equivalent on 2017-11-21. Applicant: Abbott Rapid Diagnostics. Device class: 2.

Clearance details

Applicant: Abbott Rapid Diagnostics
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2017-06-05
Decision date: 2017-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer2023-09-27
K192987 — Aina HbA1c Monitoring System 22020-03-26
K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2019-10-29

Recalls naming K171650

K-number listed on FDA's recall record

Z-1830-2025 — ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20250424
Z-2736-2024 — Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.Class II·Ongoing·Abbott Diagnostics Technologies AS·20240617

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171650.

Data sourced from openFDA. This site is unofficial and independent of the FDA.