# K030553: Arkit HBA1C

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Sep 2, 2003 after 193 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: 1 generation back to K952337 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952337: Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
ARKIT HbA1c is a laboratory test intended for the quantitative determination of hemoglobin A1c % in blood by an enzymatic method, to monitor long-term blood glucose control in individuals with diabetes mellitus. The ARKIT HbA1c Calibrator and ARKIT HbA1c Control are designed to be used with the ARKIT HbA1c test for the determination of HbA1c in blood. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K030553
Methodology: https://510kreport.com/methodology