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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.

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. 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.

The provided FDA 510(k) summary describes the HYDRASHIFT 2/4 daratumumab device, which is an in-vitro diagnostic test. It is a modification of a previously cleared device. The acceptance criteria and study details are primarily focused on demonstrating that the modified device performs equivalently to the predicate device.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the study is a comparison between the modified device (HYDRASHIFT 2/4 daratumumab with anti-daratumumab from Chinese Hamster Ovary cells, referred to as 'Candidate/Modified Device' or 'CHO') and the predicate device (HYDRASHIFT 2/4 daratumumab with anti-daratumumab murine, referred to as 'Predicate Device (K172195)' or 'murine').

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Concordance Study: A total of 51 human serum samples were used:
    • 9 negative samples (without monoclonals)
    • 21 daratumumab treated patient samples
    • 21 daratumumab spiked samples
  • Sensitivity and Efficiency Study: 3 serum samples were used:
    • 2 normal serum samples
    • 1 serum with an IgG Kappa monoclonal
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) summary for a modified device, the samples were likely acquired under institutional review board (IRB) approval for research use, but specifics are not provided. The samples referred to as "human serum samples" and "daratumumab treated patient samples" suggest human origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation method described is "electrophoregrams are evaluated visually for the presence of specific reactions." This implies visual interpretation, likely by trained laboratory personnel, but no explicit details are given about expert panels.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1). The evaluation is described as "visual," which suggests individual assessment, potentially followed by internal quality control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focused on demonstrating equivalence in performance characteristics between the modified device and its predicate, specifically around its ability to remove daratumumab interference. It did not involve comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This device is not an AI/algorithm-only device. It is an in-vitro diagnostic test kit (reagents) used in conjunction with an electrophoresis apparatus, where the final evaluation is visual and performed by a human. The "device" in this context refers to the HYDRASHIFT 2/4 daratumumab kits, which are reagents for laboratory testing.

7. The Type of Ground Truth Used

The ground truth for the performance studies appears to be based on:

• Known sample characteristics: Using "negative samples," "daratumumab-treated patient samples" (with known treatment status), and "daratumumab spiked samples" with predetermined concentrations.
• Visual evaluation of electrophoregrams: The presence or absence of specific reactions with monoclonal proteins is visually assessed, likely based on established laboratory protocols and the expected behavior of the predicate device.

It's essentially a performance comparison against known sample statuses and the established performance of the predicate device.

8. The Sample Size for the Training Set

This document does not describe a training set. This device is a reagent kit, not a machine learning or AI-based system that typically requires a training set. The performance studies are validation studies for the modified reagent.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned or implied for this type of device, this question is not applicable.

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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 M) heavy chains, and kappa (free and bound) and lambda (free and bound) light chains, respectively. After removing the nonreacted 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 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 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.

HYDRASYS 2 is a semi-automated multi-parameter system for start-to finish agarose gel electrophoresis: application of samples, migration, 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 immunoglobulins) and therefore, an indication of performing an Immunofixation technique to type and confirm the monoclonal gammopathies.

Daratumumab is a human therapeutic Ig 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.

Daratumumab CONTROL is a qualitative quality control for the assay.

The HYDRASHIFT daratumumab immunofixation procedure performed on HYDRAGEL IF 2/4 gel is based on the creation of a daratumumab / anti-daratumumab antibody complex and shifting it outside the gammaglobulins zone. With the HYDRASHIFT daratumumab procedure, the daratumumab / anti-daratumumab antibody complex is visualized in alpha-1 zone on Ig G and Kappa immunofixation tracks and then the interference is removed from the gamma zone.

The HYDRASHIFT 2/4 daratumumab device is an immunofixation electrophoresis kit designed to remove daratumumab Ig G, Kappa interference, allowing for the visual evaluation of monoclonal proteins in human serum from patients treated with daratumumab. The study to prove the device meets acceptance criteria involved repeatability, reproducibility, and external comparative studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Repeatability Study: 10 different serum samples (1 normal, 9 with monoclonal components).
• Reproducibility Study: 10 different serum samples (1 normal, 9 with monoclonal components).
• External Comparative Study No. 1: 198 serum samples.
• External Comparative Study No. 2: 172 serum samples (noted that the first 172 samples from study 1 were analyzed on both sites, implying potentially shared samples in part).

The data provenance is from "2 external studies performed in the USA." It is not explicitly stated whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The evaluation of electrophoregrams is noted as "evaluated visually," implying human interpretation, but specifics about the interpreters are absent.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1, 3+1) for the test set results. The concordance of results is reported without detailing how disagreements, if any, were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is reported in the provided text. The studies focus on the technical performance of the device (repeatability, reproducibility, and concordance with existing methods) rather than the improvement of human reader performance with or without AI assistance. The device is a "HYDRASHIFT" kit that removes interference for visual evaluation, not an AI-based interpretation system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. The device is a diagnostic kit that requires visual evaluation of electrophoregrams by a human. Its purpose is to prepare samples to remove interference for human readability, not to interpret the results automatically.

7. The Type of Ground Truth Used

The ground truth appears to be based on the established clinical characterization of the serum samples (e.g., "normal" or "pathological with monoclonal components"). For normal samples, it's the absence of monoclonal components. For pathological samples, it's the specific type of monoclonal component (e.g., Ig G, L + Ig A, K + Ig M, L). This would typically be confirmed by standard laboratory techniques and expert interpretation of immunofixation electrophoresis. The external comparative studies also use existing methods (HYDRAGEL 4 IF alone) as a comparison baseline.

8. The Sample Size for the Training Set

The document does not mention a "training set" as it is typically understood in the context of machine learning or AI. The studies performed are for device validation, focusing on performance characteristics such as repeatability, reproducibility, and comparison with predicate devices, rather than training a model.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set for an AI/algorithm, there is no information on how its ground truth would have been established. The ground truth for the validation studies (test sets) is based on the known characteristics of the serum samples and comparison with established methods.

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