# K140829: Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 14, 2014 after 104 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 K010748 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121492: Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent, Beckman Coulter, Inc. (2012) Summary page 1.

## Indications for use
The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c3) Reagent, when used in conjunction with UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC SYNCHRON Systems HbA1c3 Calibrators and HbDIL reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The A1c3 and Hb3 values generated as part of the HbA1c3 assay are intended for use in the calculation of the A1c3/Hb3 ratio and must not be used individually. Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus.

Source page: https://510kreport.com/device/K140829
Methodology: https://510kreport.com/methodology