(30 days)
Not Found
No
The description focuses on a semi-automated electrophoresis system and chemical reagents for visual evaluation of results, with no mention of AI or ML.
No
This device is for in vitro diagnostic use, specifically for qualitative detection of monoclonal proteins in human serum, which means it aids in diagnosis rather than directly treating a condition.
Yes
The device is described as being "intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis," which is a diagnostic purpose.
No
The device description explicitly mentions "semi-automated HYDRASYS 2 electrophoresis apparatus" and "agarose gels," indicating the device includes hardware components and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kit is for the "qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis." This is a diagnostic test performed on a human sample (serum) to identify a specific condition (presence of monoclonal proteins).
- Device Description: The description further elaborates on the process of using the kit to identify monoclonal proteins in serum, which is a diagnostic procedure.
- Intended User / Care Setting: It is labeled "For In Vitro Diagnostic Prescription Use Only," which is a clear indication of its IVD status.
- Performance Studies: The performance studies describe testing on human serum samples to evaluate the device's ability to detect monoclonal proteins and handle interference from daratumumab, which are typical evaluations for an IVD.
N/A
Intended Use / Indications for Use
HYDRASHIFT 2/4 daratumumab kits are to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. HYDRASHIFT 2/4 daratumumab with the HYDRAGEL IF kit are intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. 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.
Product codes (comma separated list FDA assigned to the subject device)
CFF
Device Description
HYDRASYS 2 is a semi-automated multi-parameter system for start-to finish agarose gel electrophoresis: application of samples, migration, incubation, drying, staining, destaining and final-stage drying. Abnormal bands in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspected to be monoclonal proteins (M-proteins, paraproteins, monoclonal immunoqlobulins) and therefore, an indication of performing an Immunofixation technique to type and confirm the monoclonal qammopathies. Daratumumab is a human therapeutic Iq G Kappa monoclonal antibody and as such, during the clinical monitoring of patients treated with daratumumab, this antibody simulates a band detected by serum protein electrophoresis and immunofixation in the gamma region. It can simulate an endogenous Ig G Kappa paraprotein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
4.1 Concordance
Human serum samples of (9 negative samples without monoclonals), (21 daratumumab treated patient samples), (21 daratumumab spiked samples) were compared between the predicate (anti-daratumumab murine) and modified device (anti-daratumumab chinesse hamster ovary cells). The samples demonstrated 100% concordance.
4.2 Sensitivity and Efficiency
Three serum samples (2 normal serum samples and 1 serum with a IgG Kappa monoclonal) were used in the study. Samples were mixed by adding different concentrations of daratumumab over a concentration range of 0.1 to 3.0 g/L. The detection limit (sensitivity) of the daratumumab complex at the alpha-1 zone of the G kappa tracks was visualized at 0.3 g/L the same as the predicate device. The efficiency of the shift of the daratumumab complex to the alpha-1 zone is 3.0 g/L the same as the predicate.
4.3 Stability of the anti-daratumumab
The stability of the anti-daratumumab (CHO) was tested at 2-8ºC in real time and accelerated studies using two lots of anti-daratumumab. Some studies are still on going. The shelf life is 2 years at 2-8ºC the same as the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The samples demonstrated 100% concordance.
The detection limit (sensitivity) of the daratumumab complex at the alpha-1 zone of the G kappa tracks was visualized at 0.3 g/L the same as the predicate device.
The efficiency of the shift of the daratumumab complex to the alpha-1 zone is 3.0 g/L the same as the predicate.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 2019
Sebia Karen Anderson Director of Regulatory and Technical 1705 Corporate Drive, Suite 400 Norcross, Georgia 30093
Re: K190851
Trade/Device Name: HYDRASHIFT 2/4 daratumumab Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E immunological test system Regulatory Class: Class II Product Code: CFF Dated: March 5, 2019 Received: April 2, 2019
Dear Karen Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Doug Jeffery Acting Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190851
Device Name HYDRASHIFT 2/4 daratumumab
Indications for Use (Describe)
HYDRASHIFT 2/4 daratumumab kits are to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. HYDRASHIFT 2/4 daratumumab with the HYDRAGEL IF kit are intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510K SUMMARY (Summary of Safety and Effectiveness)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Sebia, Inc. |
|---|---|
| Address | 1705 Corporate Drive Suite 400 |
| Norcross, Georgia 30093, USA | |
| Contact | Karen Anderson, Dir of Technical and Regulatory |
| Phone: 1-800-835-6497 | |
| Fax: 770-446-8511 | |
| Email: karen.anderson@sebia-usa.com | |
| Matthew C. Wagner, Ph.D | |
| Scientific Affairs Specialist | |
| Phone: 1-800-835-6497 | |
| Email: matthew.wagner@sebia-usa.com | |
| Date Prepared | March 5, 2019 |
| Manufacturing | Sebia |
| Parc Technologique L\u00e9onard de Vinci | |
| Rue L\u00e9onard de Vinci, | |
| CP 8010 LISSES, 91008 EVRY Cedex | |
| FRANCE | |
| Phone: (33) 1 69 89 80 80 | |
| Fax: (33) 1 69 89 78 78 | |
| Product Name | HYDRASHIFT 2/4 daratumumab |
| Common Name | Hydrashift daratumumab Serum Immunofixation |
| Product Regulation No. | 21CFR sec. 866.5510 |
| Product Codes | CFF |
| Device classification and Panel | |
| Classification | Class II , Immunology (82) |
| Establishment Registration No. | 8023024 |
| Predicate Devices | The candidate device is a modification of the |
| predicate device. The device name , HYDRASHIFT | |
| 2/4 daratumumab, is unchanged from how it was | |
| cleared in 510(k) K172195 |
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1. DEVICE DESCRIPTION
HYDRASYS 2 is a semi-automated multi-parameter system for start-to finish agarose gel electrophoresis: application of samples, migration, incubation, drying, staining, destaining and final-stage drying.
Abnormal bands in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspected to be monoclonal proteins (M-proteins, paraproteins, monoclonal immunoqlobulins) and therefore, an indication of performing an Immunofixation technique to type and confirm the monoclonal qammopathies.
Daratumumab is a human therapeutic Iq G Kappa monoclonal antibody and as such, during the clinical monitoring of patients treated with daratumumab, this antibody simulates a band detected by serum protein electrophoresis and immunofixation in the gamma region. It can simulate an endogenous Ig G Kappa paraprotein.
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 bv electrophoresis on alkaline buffered agarose gels, are incubated with individual antisera that are specific against gamma (lg G), alpha (lg A) and mu (lg 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 lg 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.
510(k) Summary 2
5
For In Vitro Diagnostic Prescription Use Only.
Note: The intended use of the modified device, as described in its labeling, has not changed as the result of the modification.
3. TECHNOLOGICAL CHARACTERISTICS
The candidate device, HYDRASHIFT 2/4 daratumumab, has been modified from the predicate device with the addition to the package insert labeling as follows:
- Additional to the Anti daratumumab reagent provided in the kit, . The anti-daratumumab antiserum is ready to use. It contains anti-daratumumab total immunoglobulins from Chinese hamster ovary cells (CHO). For easy identification of the antiserum and as an aid in monitoring its application, the antiserum is colored with distinct nonhazardous dye that matches the color of the vial label.
The following tables compare the HYDRASHIFT 2/4 daratumumab with its predicate device, HYDRASHIFT 2/4 daratumumab (K172195)
| Table 1: Assay Comparison
Item | HYDRASHIFT 2/4 daratumumab
Predicate Device (K172195) | HYDRASHIFT 2/4 daratumumab
Candidate/Modified
Device |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended 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. | Same |
| Instrumentation | Sebia HYDRASYS 2 | Same |
Table 1: Assav Comparison
510(k) Summary 3
6
| Immunofixation (
IF) test kits used
in conjuction with
the HYDRASHIFT
2/4 daratumumab | HYDRAGEL 4 IF Acid violet
Standard mask,
HYDRAGEL 4 IF Acid violet
Dynamic mask. | Same |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------|
| Scientific
Technology | Agarose Gel Electrophoresis | Same |
| Specimen Type | Serum | Same |
| Results | Qualitative | Same |
| Sensitivity/ Lowest detectable
daratumumab limit | The detection limit of daratumumab
and / or daratumumab / anti-
daratumumab antibody
complexvisualized is 0.3 g/L | Same |
| Efficiency ( Maximum removal of
complex) | 3.0 g/L | Same |
| Daratumumab
band
when
HYDRASHIFT
treated
with
daratumumab kit | Removed from gamma zone into
alpha zone | Same |
| Stability of the anti-daratumumab
reagent
Stability 2 to 8ºC | 2 years | Same |
| daratumumab Control | daratumumab control (K172195) | Same |
Table 2: Assay Comparison, Labelled Performance Characteristics
| Item | HYDRASHIFT 2/4 daratumumab
Predicate Device (K172195) | HYDRASHIFT 2/4 daratumumab
Candidate/Modified Device |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Package Insert
Labeling | The anti-daratumumab
antiserum is ready to use.
It contains murine anti-
daratumumab total
immunoglobulins.
For easy identification of the
antiserum and as an aid in
monitoring its application, the
antiserum is colored with distinct
nonhazardous dye that matches
the color of the vial label. | The anti-daratumumab antiserum is
ready to use. It contains anti-
daratumumab total immunoglobulins
from Chinese hamster ovary cells. For
easy identification of the antiserum and
as an aid in monitoring its application, the
antiserum is colored with distinct
nonhazardous dye that matches the color
of the vial label |
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Table 3: Kit and Components
| HYDRASHIFT 2/4 daratumumab (K172195) | HYDRASHIFT 2/4 daratumumab | ||||
|---|---|---|---|---|---|
| Items | PN 4639 (20 TESTS) | PN 4640 (40 TESTS) | Items | PN 4639 (20 TESTS) | PN 4640 (40 TESTS) |
| Anti- daratumumab mouse antiserum ( ready to use) | 1 vial, 0.4 mL | 1 vial, 0.85mL | Anti- daratumumab Chinese hamster ovary cells antiserum ( ready to use) | 1 vial, 0.4 mL | 1 vial, 0.85 mL |
| Sample diluent (ready to use) | 1 vial, 2.2 mL | 1 vial, 2.2 mL | Sample diluent (ready to use) | Same | Same |
| Green applicators | 1 pack of 10 | 2 pack of 10 | Green applicators | Same | Same |
4. Performance Data:
To address the modifications the following studies were conducted to validated the performance of the modified anti-daratumumab (CHO).
4.1 Concordance
Human serum samples of (9 negative samples without monoclonals), (21 daratumumab treated patient samples), (21 daratumumab spiked samples) were compared between the predicate ( anti-daratumumab murine) and modified device ( anti-daratumumab chinesse hamster ovary cells).
The samples demonstrated 100% concordance.
4.2 Sensitivity and Efficiency
Three serum samples (2 normal serum samples and 1 serum with a IgG Kappa monoclonal) were used in the study. Samples were mixed by adding different concentrations of daratumumab over a concentration range of 0.1 to 3.0 g/L. The detection limit (sensitivity) of the daratumumab complex at the alpha-1 zone of the G kappa tracks was visualized at 0.3 g/L the same as the predicate device. The efficiency of the shift of the daratumumab complex to the alpha-1 zone is 3.0 g/L the same as the predicate.
4.3 Stability of the anti-daratumumab
The stability of the anti-daratumumab (CHO) was tested at 2-8ºC in real time and accelerated studies using two lots of anti-daratumumab. Some studies are still on going. The shelf life is 2 years at 2-8ºC the same as the predicate.
8
5. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision. The differences between the predicate and candidate device do not impact the indications for use or technical performance of the assay.