510(k) Report

Devices descending from K050574

9 later devices reach Afinion Hbalc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics201722
+1K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS20156—
+1K110056Afinion AnalyzerAxis-Shield Poc AS20118—
+2K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation20240—
+2K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS20230—
+2K192987Aina HbA1c Monitoring System 2Jana Care, Inc.20200—
+2K180509Quo-Test A1c SystemEkf-Diagnostic GmbH20190—
+2K173127skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…Skyla Corporation H.S.P.B20180—
+2K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSd Biosensor, Inc.20150—