# K131580: Automated Gylcohemoglobin Analyzer HLC-723G8

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Jan 23, 2014 after 237 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130002 (2013). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130002: Tina-Quant HBA1C Gen. 2 Test System, Roche Diagnostics (2013). Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K171861: CAPILLARYS Hb A1c (2018), 0 descendants of its own
- K171537: CAPI 3 Hb A1c (2017), 0 descendants of its own
- K162822: ADAMS A1c HA-8180V, CALIBRATOR 80 (2017), 0 descendants of its own

## Recalls of this device
- Jul 13, 2018 · Class II · Z-3244-2018: Analyzers were distributed with software which lacks a 510K
- Nov 7, 2016 · Class II · Z-1225-2017: The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of H

## Indications for use
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

Source page: https://510kreport.com/device/K131580
Methodology: https://510kreport.com/methodology