# K162822: ADAMS A1c HA-8180V, CALIBRATOR 80

- Pathway: 510(k) (Traditional)
- Applicant: Arkray Factory, Inc.
- Decided: Jun 29, 2017 after 265 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972265 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131580: Automated Gylcohemoglobin Analyzer HLC-723G8, Tosoh Bioscience, Inc. (2014) Summary page 5.
- K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8, Tosoh Bioscience, Inc. (2008) Summary page 5.

## Indications for use
The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC). Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The ADAMS A1c HA-8180V is intended for Professional Use Only. The CALIBRATOR 80 is for the calibration of the ADAMS A1c HA-8180V system used for the quantitative determination of hemoglobin A1c in human whole blood and hemolysate samples. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K162822
Methodology: https://510kreport.com/methodology