Medconn 8K Glycated Hemoglobin Test System

The Medconn 8K Glycated Hemoglobin Test System is an ion-exchange HPLC analyzer that quantitatively measures hemoglobin A1c (HbA1c) in human whole blood or hemolysate. It is used as an aid in diagnosing diabetes, identifying patients at risk for diabetes mellitus, and monitoring long-term blood glucose control in diabetic patients.

Both the subject device and predicate use ion-exchange HPLC technology to separate hemoglobin species based on ionic interactions. The subject device has a slightly narrower measuring interval (3.0–17.0% NGSP vs. 3.5–20% NGSP for the predicate) but accepts K2-EDTA whole blood samples and supports two operation modes (whole blood and dilution). Both are traceable to DCCT reference methods and IFCC, certified via NGSP.

CLSI EP05-A3 (precision), CLSI EP06-A2 (linearity), CLSI EP07-A3 (interference testing), CLSI EP09c 3rd Edition (method comparison). Standardization traceable to IFCC reference calibrators and DCCT reference method, certified via NGSP.

The subject device and predicate D-100™ HbA1c share the same intended use, principle of operation (ion-exchange HPLC), regulatory class (Class II), and user environment. Both measure HbA1c in whole blood for the same clinical purposes. Analytical performance validation demonstrates equivalent precision, linearity, and accuracy across the claimed measuring range, with negligible bias relative to NGSP reference methods. The minor difference in measuring interval does not raise new safety or effectiveness concerns.