# K173206: SEKURE HbA1c Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sekisui Diagnostics P.E.I., Inc.
- Decided: Jul 12, 2018 after 283 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 K934070 (1994). 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)
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls, Abbott Laboratories (2014) Summary page 5.

## Indications for use
The SEKURE HbA1c assay is used to measure the percent concentration of hemoglobin A1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate on the SK500 Clinical Chemistry System. Measurement of HbA1c is used as an aid in the diagnosis of diabetes mellitus, as an aid in the identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K173206
Methodology: https://510kreport.com/methodology