# K232027: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Apr 4, 2024 after 272 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
Longest line of descent: 1 generation back to K091283 (2010). 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)
- K091283: Capillarys Neonat HB (PN 2006), Sebia (2010) Summary page 6.

## Indications for use
The CAPI 3 NEONAT Hb kit is intended as a qualitative screen for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D and Bart’s) in blood from human new-born collected on filter paper. This analysis is performed by capillary electrophoresis with the CAPILLARYS 3 DBS instrument. The CAPILLARYS 3 DBS instrument is a capillary electrophoresis based automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins (A, F, S, C, D, E and Bart’s). The assay is performed on the hemolysate of whole blood samples previously collected on filter paper. The test result must be interpreted in conjunction with other biological and clinical findings. In case of abnormal hemoglobin presence, it should be confirmed by additional tests as per local recommendations. The device is intended for professional use only. For In Vitro Diagnostic Use only.

Source page: https://510kreport.com/device/K232027
Methodology: https://510kreport.com/methodology