# K200904: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Aug 5, 2021 after 486 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K122472: Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System, Bio-Rad Laboratories, Inc., Clinical Systems Divis (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K142448: VARIANT II TURBO HbA1c Kit - 2.0, Bio-Rad Laboratories, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K250073: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (2025), 0 descendants of its own

## Indications for use
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in venous whole blood 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/K200904
Methodology: https://510kreport.com/methodology