# K112491: Sebia Capillarys Hemoglobin (E) with Capillarys 2

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: May 24, 2012 after 269 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K192931: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (2022), 0 descendants of its own

## Indications for use
The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use. The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A,A2 and. F and for the detection of major hemoglobin variants S, C. E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant. For/In V/tmo Diagnostic Use.

Source page: https://510kreport.com/device/K112491
Methodology: https://510kreport.com/methodology