Cleared Traditional

K203184 - HYDRASHIFT 2/4 isatuximab

K203184 is an FDA 510(k) clearance for HYDRASHIFT 2/4 isatuximab, manufactured by Sebia. The device is a Class 2 Immunology device with product code CFF cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K203184 · Sebia · Immunology device
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Nov 2021
Decision
381d
Days
Class 2
Risk

K203184 is an FDA 510(k) clearance for the HYDRASHIFT 2/4 isatuximab. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 12, 2021 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sebia devices

FDA 510(k) Submission Details - K203184

510(k) Number K203184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2020
Decision Date November 12, 2021
Days to Decision 381 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 105d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFF Device Classification - Class 2, Special Controls

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 26
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K203184.
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · Sebia · Nov 2019
HYDRASHIFT 2/4 daratumumab
K190851 · Sebia · May 2019
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · Sebia · Jan 2018
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · Sebia · Dec 2016
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · Sebia · Jan 2015
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · Grifols USA, LLC · Aug 2012