# K011434: G7 Automated HPLC Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Sep 18, 2001 after 131 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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 K972265 (1997). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972265: A1C 2.2 Plus - Automated Glycohemoglobin Analyzer, Tosoh Medics, Inc. (1997) Summary page 1.

## Most influential descendants
- K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8 (2008), 4 descendants of its own
- 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
- K081895: Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators (2009), 1 descendant of its own
- K072686: Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls (2008), 1 descendant of its own

## Recalls of this device
- Feb 10, 2015 · Class III · Z-2066-2015: The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
- Aug 18, 2010 · Class III · Z-1075-2013: The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages

## Indications for use
The G7 Automated HPLC Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated hemoglobin measurements obtained by this device are used in the management and treatment of diabetes.

Source page: https://510kreport.com/device/K011434
Methodology: https://510kreport.com/methodology