# K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Sep 16, 2008 after 512 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972265 (1997). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011434: G7 Automated HPLC Analyzer, Tosoh Medics, Inc. (2001)

## Most influential descendants
- K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C (2012), 2 descendants of its own
- K133344: Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys Calibrators (2014), 1 descendant of its own
- K162822: ADAMS A1c HA-8180V, CALIBRATOR 80 (2017), 0 descendants of its own
- K162281: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (2017), 0 descendants of its own

## Recalls of this device
- 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 G8 Automated Glycohemoglobin Analyzer HLC-723G8 is intended for INVITRO DIAGNOSTIC USE for the measurement of hemoglobin Al c (HbAl c) in whole blood specimens. Alc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. The AlC Calibrator Set is a reference agent designed for calibrating Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.

Source page: https://510kreport.com/device/K071132
Methodology: https://510kreport.com/methodology