# K072686: Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Mar 17, 2008 after 175 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
Longest line of descent: 2 generations back to K972265 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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) Summary page 2.

## Most influential descendants
- K121842: Architect HBA1C, Architect HBA1C, and Architect HBA1C (2012), 0 descendants of its own

## Indications for use
Reagents The AxSYM HbAlc assay is an immunoassay for the quantitative determination of percent hemoglobin Alc (HbAlc) in whole blood samples on the AxSYM System. Percent HbAlc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. Calibrators The AxSYM HbAlc Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of percent HbAlc in whole blood samples. Controls The AxSYM HbAlc Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM HbAlc assay when used for the quantitative determination of percent hemoglobin Alc (HbAlc) in whole blood samples on the AxSYM System.

Source page: https://510kreport.com/device/K072686
Methodology: https://510kreport.com/methodology