HYDRASHIFT 2/4 daratumumab

K190851 · Sebia · CFF · May 2, 2019 · Immunology

Device Facts

• Record ID: K190851
• Device Name: HYDRASHIFT 2/4 daratumumab
• Applicant: Sebia
• Product Code: CFF · Immunology
• Decision Date: May 2, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Indications for Use

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.

Device Story

In vitro diagnostic test; detects daratumumab in human serum; utilizes anti-daratumumab total immunoglobulins; raw material source transitioned from murine to Chinese hamster ovary (CHO) cells; used in clinical laboratory settings by trained personnel; results assist in monitoring or identifying presence of therapeutic monoclonal antibody; modification maintains fundamental scientific technology of original cleared device (K172195).

Clinical Evidence

Bench testing only. Performance studies included concordance, sensitivity, and stability testing to validate the impact of the raw material source change from murine to Chinese hamster ovary cells.

Technological Characteristics

In vitro diagnostic assay; utilizes anti-daratumumab total immunoglobulins derived from Chinese hamster ovary cells; qualitative detection method; performance characteristics verified via concordance, sensitivity, and stability testing.

Indications for Use

Indicated for qualitative detection of monoclonal proteins in human serum via immunofixation electrophoresis in patients receiving daratumumab therapy to mitigate daratumumab-induced interference.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• HYDRASHIFT 2/4 daratumumab test (K172195)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: K190851

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device.

HYDRASHIFT 2/4 daratumumab test (K172195)

2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials. The labeling was updated with the change to the Preparation section on page 5 to include “It contains anti-daratumumab total immunoglobulins from chinese hamster ovary cells.” The changes do not affect the intended use.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for :

a. Change of animal source for the raw material of the Ig Anti-daratumumab from murine (original material) to Chinese hamster ovary cells (new material).

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and performance studies including concordance, sensitivity, and stability was provided..

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.