# K182651: HbA1c Advanced

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Jan 16, 2019 after 114 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: 4 generations back to K926469 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack, Bio-Rad Laboratories, Inc. (2015) Summary page 4.

## Indications for use
The HbA1c (Hemoglobin A1c) Advanced assay on the Beckman Coulter DxC700 AU Clinical Chemistry Analyzer, is intended for the quantitative determination of mmol/mol HbA1c (IFCC) or % HbA1c (DCCT/NGSP) concentration in human venous whole blood. The determination of HbA1c is used as an aid in the diagnosis of diabetes mellitus, for the monitoring of long-term glucose control in individuals with diabetes mellitus and identifying patients who may be at risk for developing diabetes mellitus. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K182651
Methodology: https://510kreport.com/methodology