# K082227: Minicap Hemoglobin (E) Kit, Model 2207, 2227

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Mar 26, 2009 after 231 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7415
- 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 MINICAP HEMOGLOBIN(E) kit :is designed. for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative analysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis.

Source page: https://510kreport.com/device/K082227
Methodology: https://510kreport.com/methodology