510(k) · Cleared
ClearedHYDRASHIFT 2/4 isatuximab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Nov 12, 2021 as substantially equivalent to K960669 (Morax, 1996) after a 381-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 12, 2021
- Review
- 381 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960669 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960669 Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, &…Morax · 1996
- This deviceK203184 HYDRASHIFT 2/4 isatuximabSebia · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits | Morax | 1996 | — |
| 0 (this device) | K203184 | HYDRASHIFT 2/4 isatuximab | Sebia | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF KitsSummary page 6…Name Predicate Device Product Code Regulation No. 510(k) number HYDRAGEL IF K960669 CFF 866.5510 510(k) Summary 3 Similarities be… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K960669.
How does its category compare?
All CFF devicesCFF Immunoelectrophoretic, Immunoglobulins, (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CFF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CFF
Too few CFF 510(k)s in any year since 2007 to give a median.
Recalls per year · CFF
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFF
1in 2021
MAUDE reports naming product code CFF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203184: HYDRASHIFT 2/4 isatuximab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203184
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026