# K220999: Hipro Glycosylated Hemoglobin (HbA1c) Test System

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hipro Biotechnology Co., Ltd.
- Decided: Sep 12, 2024 after 892 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
The Hipro® Glycosylated Hemoglobin (HbAlc) Test System comprised of the Hipro Glycosylated hemoglobin (HbAlc) test kit and the HP-AFS/1 automatic immunoassay analyzer is used as an aid in diagnosis of diabetes mellitus, 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. It is an in vitro diagnostics reagent system intended for quantitative determination of% hemoglobin Ale (DCCT/NGSP) in venous whole blood.

Source page: https://510kreport.com/device/K220999
Methodology: https://510kreport.com/methodology