# K052291: Capillary's Hemoglobin (E) (PN 2007)

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Jun 27, 2006 after 308 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. The FDA summary names no predicate by number.

## Indications for use
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the detection and the characterization of hemoglobins in human blood with the Sebia CAPILLARYS system, for capillary electrophoresis. The CAPILLARYS performs all procedural sequences automatically to obtain a hemoglobin profile. The CAPILLARYS system automatically mixes the blood sample with hemolysing solution The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The electrophoregrams are evaluated visually for the pattern abnormalities. Direct detection of the hemoglobins provides relative quantification of individual hemoglobin fraction of the normal hemoglobin fractions A, A2, F and for the detection of major hemoglobin variants as S, C, E and D using Capillarys electrophoresis For in vitro diagnostic use

Source page: https://510kreport.com/device/K052291
Methodology: https://510kreport.com/methodology