# K250073: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Oct 3, 2025 after 266 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: 1 generation back to K200904 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200904: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8, Tosoh Bioscience, Inc. (2021) Summary page 5.

## Indications for use
The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC). This test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K250073
Methodology: https://510kreport.com/methodology