# K042459: Synchron LX Systems Hemoglobin A1C2 (HBA1C2) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 17, 2004 after 68 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.
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)
- K010748: Synchron Systems Hemoglobin A1C Reagent, Beckman Coulter, Inc. (2001) Summary page 1.

## Indications for use
The Hemoglobin Alc2 (HbAlc2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbAlc2 Calibrators, is intended for the quantitative determination of hemoglobin Alc (HbAlc2) concentration as a percentage of total hemoglobin in human whole blood. Measurement of hemoglobin Alc is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin Alc provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.

Source page: https://510kreport.com/device/K042459
Methodology: https://510kreport.com/methodology