# K063209: HBA1C; Calibrator; Control Normal, Control Abnormal

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron OY
- Decided: Mar 21, 2007 after 149 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The hemoglobin Alc (HbAlc) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin Al c (HbAl c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbAlc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Source page: https://510kreport.com/device/K063209
Methodology: https://510kreport.com/methodology