# K972265: A1C 2.2 Plus - Automated Glycohemoglobin Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Sep 25, 1997 after 100 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K011434: G7 Automated HPLC Analyzer (2001), 11 descendants of its own
- K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8 (2008), 4 descendants of its own
- K041764: The Vitros 5,1 FS Chemistry System (2004), 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

## Indications for use
The A1c 2.2 Plus Automated Glycohemoglobin 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/K972265
Methodology: https://510kreport.com/methodology