# K121492: Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 11, 2012 after 113 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 K010748 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010748: Synchron Systems Hemoglobin A1C Reagent, Beckman Coulter, Inc. (2001) Summary page 1.

## Most influential descendants
- K140829: Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent (2014), 0 descendants of its own

## Indications for use
The Hemoglobin Aic- reagent, when used in conjunction with UniCel® DxC 6001800 SYNCHRON® Systems, UniCel® DxC SYNCHRON® Systems HbAlc- Calibrators and SYNCHRON® and AU® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin Aic concentration in human whole blood. Measurement of hemoglobin Aic measures long-term glycemic control in patients with diabetes mellitus.

Source page: https://510kreport.com/device/K121492
Methodology: https://510kreport.com/methodology