510(k) · Cleared

Cleared

HYDRASHIFT 2/4 daratumumab, daratumumab Control

K172195510(k) TraditionalCleared Jan 11, 2018174-day reviewClass II21 CFR 866.5510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sebia · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Cleared on Jan 11, 2018 as substantially equivalent to K960669 (Morax, 1996) after a 174-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jan 11, 2018
Review: 174 days
Class: Class II
Product code: CFF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960669 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK960669 Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, &…Morax · 1996
This deviceK172195 HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebia · 2018
Descendant · cites it directly · 0 of its ownK190851 HYDRASHIFT 2/4 daratumumabSebia · 2019

Most influential descendants

Showing 1 of 1 · See all

K190851HYDRASHIFT 2/4 daratumumabSebia · 2019 · cites it directly0descendants

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)	K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	Sebia	2018	—
+1	K190851	HYDRASHIFT 2/4 daratumumab	Sebia	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K172195, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Top candidate predicates for a new CFF device

#1 K203184 HYDRASHIFT 2/4 isatuximabscore 2.3 · 1 generation · no Class I recall

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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	Applicant	Decided	Recalls
*	K960669	Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits Summary page 6 …ice Product Code Regulation 510(k) number No. HYDRAGEL IF K960669 CFF 866.5510 510(k) Summary 3…	Morax	1996	—

Also cleared against K960669: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K190851	HYDRASHIFT 2/4 daratumumab	Sebia	2019	0

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.
Of its descendants, K190851 (Sebia, 2019) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K960669.

How does its category compare?

All CFF devices

CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · CFF

1in 2021

2007high 2 (2009) · low 0 (2007)2026

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

2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CFF

1in 2021

2007high 1 (2012) · low 0 (2007)2025

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?

Read the full statement (200 words)

The HYDRASHIFT 2/4 daratumumab test is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The kits are to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. The proteins, separated by electrophoresis on alkaline buffered agarose gels, are incubated with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) and lambda (free and bound) light chains, respectively. After removing the non-reacted proteins, the immunoprecipitates are stained with acid violet. The electrophoregrams are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 daratumumab kits remove the daratumumab Ig G, Kappa interference and enable the visual evaluation of the presence or absence of monoclonal proteins on the HYDRAGEL IF kits in patients who have received daratumumab therapy. For In Vitro Diagnostic Prescription Use Only.

The daratumumab Control is designed for qualitative quality control of the HYDRASHIFT daratumumab immunofixation procedure performed using the HYDRASYS 2 instrument. The daratumumab Control is designed for laboratory use. It should be used like a human serum. For In Vitro Diagnostic Prescription Use Only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172195 · printed Nov 4, 2026

Cite this page

510(k) Report. “K172195: HYDRASHIFT 2/4 daratumumab, daratumumab Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172195

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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