# K100547: Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set, Elitech Clinical

- Pathway: 510(k) (Traditional)
- Applicant: Seppim S.A.S.
- Decided: May 19, 2011 after 448 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 K031539 (2003). 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)
- K031539: Hemoglobin A1C Reagent Set, Pointe Scientific, Inc., (2003) Summary page 1.

## Indications for use
ELiTech Clinical Systems HbAlc is intended for use in the quantitative in vitro diagnostic determination of hemoglobin Aic (HbAlc) in human whole blood on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. HbAlc measurements are used for the monitoring of long term blood glucose control in diabetic patients. ELITech Clinical Systems HbAlc Calibrator set is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbAl c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use. ELiTech Clinical Systems HbAlc Control L+H is a quality control with .2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELiech Clinical Systems HbAlc on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.

Source page: https://510kreport.com/device/K100547
Methodology: https://510kreport.com/methodology