# K242911: Medconn Glycated Hemoglobin Test system

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Medconn Medical Technology Co., Ltd.
- Decided: Jun 20, 2025 after 269 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926469 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack, Bio-Rad Laboratories, Inc. (2015) Summary page 6.

## Indications for use
Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood or hemolysate with ion-exchange high performance liquid chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K242911
Methodology: https://510kreport.com/methodology