# K091283: Capillarys Neonat HB (PN 2006)

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Feb 22, 2010 after 297 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
- K232027: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (2024), 0 descendants of its own

## Indications for use
The CAPILLARYS NEONAT Hb* kit Is designed for the separation of the normal hemoglobins (F and A) in. blood sariiples from human. new-borne, and for the detection of the major hemoglobin variants (S,C, E, 0 and BDe~s), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use. The CAPILILARYS 2 Is artautomnated~anaiyzer which perfotms: a complete hemoglobin profile for the qualitative analysis of hemogloblns; The assay is performed on the hemolysate of whole blood samples previously collected on filter paper. The Hb AF Control Isdesigned: -for the migration control before starting a new analysis sequence and for the qualitative quality control, for human hemoglobins A and F with the SEBIA CAPILLARYS NEONAT Hb electrophoresls procedure used with the CAPILLARYS 2system, and, - for the quantitative quality control for detection of the human hemoglobins A, Fand A2 with the SEBIA electrophoresis procedures : HYDRAGEL HEMOGLOBIN(E) used with the HYDRASYS system, CAPILLARYS HEMOGLOBIN(E) used with the CAPILLARYS system and MINICAP HEMOGLOBIN(E) used with the MINICAP system. The Hb AFR Control Is designed for laboratory use. It should be used (wilth Its bar code label for the CAPILLARYS and MIN ICAP procedures) like a normal human blood. The values obtained must fall within the range provided with each batch of Hb AF Control.

Source page: https://510kreport.com/device/K091283
Methodology: https://510kreport.com/methodology