# K203184: HYDRASHIFT 2/4 isatuximab

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Nov 12, 2021 after 381 days
- Product code: CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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 K960669 (1996). 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)
- K960669: Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits, Morax (1996) Summary page 6.

## Indications for use
The HYDRASHIFT 2/4 isatuximab kit is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The HYDRASHIFT 2/4 isatuximab kit is to be used in conjunction with the HYDRAGEL IF kit and the semi-automated HYDRASY'S 2 electrophoresis apparatus. The electropherograms are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 isatuximab kit removes isatuximab [gG kappa interference and enables the visual evaluation of the presence or absence of monoclonal proteins on HYDRAGEL IF kits in patients who have received isatuximab therapy.

Source page: https://510kreport.com/device/K203184
Methodology: https://510kreport.com/methodology