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The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 mm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

For In Vitro Diagnostic Use.

The IT / IF Control is designed to qualitative detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods :

• Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP instrument,

• Immunofixation methods : SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.

The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.

The electrophoretic pattern obtained is specific for each batch of IT / IF control.

For In Vitro Diagnostic Use.

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in liquid solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses.

In CAPI 3 MMUNUOTYPING kit contains the sample diluent and specific antisera against gamma (Ig G), alpha (Ig A), mu (Ig M) heavy chains, and free and bound Kappa and Lambda light chains. A sample dilution is prepared and injected at the anodic end of six capillaries. The reference pattern (ELP pattern), which is a complete electrophoretic pattern of the sample's proteins, is obtained by mixing the sample with the ELP solution and injection into the 1st capillary. The antisera patterns are obtained by sample aspiration into the 5 subsequent capillaries separation is performed in a high voltage electrical field and detected using absorbance at 200 nm.

The IT / IF control contains three monoclonal proteins which can be used as a qualitative control with the CAPI IMMUNOTYPING kit on the CAPILLARYS 3 TERA instrument.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table. However, the method comparison study provides the performance benchmark against the predicate device.

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

• Sample Size for Method Comparison (Test Set): 115 serum samples (12 normal, 103 pathological).
• Data Provenance: Not explicitly stated as country of origin. The manufacturing information (Sebia, FRANCE) implies the device developer is French, but the source of the samples is not provided. The study is retrospective as it compares results from existing clinical samples.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The comparison is made against a "predicate device" (CAPILLARYS IMMUNOTYPING procedure), which implies the predicate device's results are considered the reference or "ground truth" for this study. The visual evaluation of electrophoregrams is mentioned, which typically involves trained laboratory personnel or pathologists, but specifics are missing.

4. Adjudication Method

Not explicitly stated. The study reports 100% agreement, suggesting no significant discrepancies arose that would require an adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done based on the provided text. The study compares the device's performance to a predicate device, not human readers with and without AI assistance.

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

Yes, the method comparison study appears to be a standalone performance evaluation of the CAPI 3 IMMUNOTYPING procedure (algorithm + instrument system) against the predicate device's procedure. While the "electrophoregrams are evaluated visually," the 100% agreement is attributed to the techniques rather than individual human interpretations.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the results obtained from the predicate device (CAPILLARYS IMMUNOTYPING procedure). This means the predicate device's ability to detect and characterize monoclonal proteins served as the reference standard.

8. The Sample Size for the Training Set

The document does not mention a training set nor does it explicitly describe an AI/machine learning component that would require a distinct training set. The device appears to be a diagnostic instrument based on capillary electrophoresis, not an AI-driven interpretation tool.

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

Since no training set or AI component is described, this information is not applicable.

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The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The CAPILLARYS, CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively .

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

For In Vitro Diagnostic Use.

The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods:

• Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments and on SEBIA MINICAP instrument.
• Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, . HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.

The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control.

For In Vitro Diagnostic Use.

This submission includes:

• 1. CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 instrument (PN 1222) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions.
• 2. IT / IF Control (PN 4788) with the new device CAPILLARYS 2 instrument (PN 1222). The IT / IF Control was cleared in prior 510K submissions.
• 3. CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 FLEX PIERCING instrument (PN 1227) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions

The configurations of the CAPILLARYS IMMUNOTYPING kits consist of the components summarized in Tables I and II. Additional details are provided in Package Inserts included in Section III of the submission. Each kit with instrument is supplied with Package Insert/manual which contains instruction for use and all the necessary information on the components needed to run the test that are sold separately. Each Package insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately.

The provided document describes a 510(k) premarket notification for "CAPILLARYS IMMUNOTYPING" and "IT / IF CONTROL" systems. It focuses on demonstrating the substantial equivalence of these systems when used with the CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for device performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. The reported device performance is presented in terms of this equivalence across various aspects.

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

The document provides limited specific details on the sample sizes used for the comparative studies.

• "CAPILLARYS IMMUNOTYPING KIT" (reagents): The reagents were previously cleared in K042939 (serum) and K082085 (urine). These prior submissions would contain the detailed sample sizes for the reagent validation. The current submission re-uses these validated reagents with new instruments.
• "IT / IF Control": The control was previously cleared in K101863. Like the reagents, the specific sample sizes for its validation with its original predicate would be in that prior submission. The current submission compares its performance on the CAPILLARYS 2.

The document states that "performance and comparative studies... were performed using Sebia's commercially available materials and standard procedures." It does not specify the country of origin of the data or explicitly state whether the studies were retrospective or prospective, though the nature of comparative studies for substantial equivalence often involves prospective testing with clinical samples or characterized controls.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for the test sets. The "electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins," which implies a visual interpretation by trained personnel. Given that these are IVD devices, it is implied that laboratory professionals/medical technologists would be involved in interpretation, but specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The evaluation is described simply as "evaluated visually," suggesting a direct interpretation rather than a multi-reader adjudication process as seen in some imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is an automated electrophoresis system for immunotyping, where the output (electrophoregrams) is visually interpreted. The focus is on the performance of the integrated system (reagent + instrument) compared to existing methods, rather than assessing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

The device is an automated electrophoretic system that separates and detects proteins. The "electrophoregrams are evaluated visually." This implies that the device provides the raw data, and human interpretation is still part of the diagnostic process. Therefore, a standalone (algorithm only) performance is not directly applicable in the context of this description, as it's not a fully automated diagnostic algorithm without human interaction. The device performs "all procedural sequences automatically to obtain a protein profile for qualitative analysis," but the final "evaluation" is still visual.

7. Type of Ground Truth Used

The ground truth is not explicitly stated as pathology, outcomes data, or expert consensus in this summary. However, given the nature of immunotyping, the ground truth for "detection and characterization of monoclonal proteins" would typically be established by established laboratory methods, often including confirmation by other techniques or clinical correlation. The comparison to predicate devices (Sebia HYDRAGEL IF kit, Paragon CZE 2000 IFE/s Control) implies that the ground truth for the samples used in the study was established by these well-accepted, previously cleared methods.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. This submission focuses on demonstrating substantial equivalence of the device and its components to existing, cleared devices. It's likely that any "training" or development data for the underlying technology (e.g., the reagents, instrument algorithms) would have occurred prior to the predicate device clearances (K042939, K082085, K101863) or during the development of the instruments themselves (K112550, K122101 for other assays). This 510(k) is about demonstrating the new combination's equivalence.

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

As no training set is explicitly discussed in the context of this 510(k) summary, how its ground truth was established is not detailed.

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The IT / IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kaopa and Lambda) with the electrophoresis methods:

• Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument.
• Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, -HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
  The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample.
  The electrophoretic pattern obtained is specific for each batch of IT/IF control.
  For In Vitro Diagnostic Use.

Not Found

The provided text is a 510(k) premarket notification letter for an in vitro diagnostic quality control material called "IT/IF Control." It is not a medical device that performs a diagnosis or uses AI. Therefore, most of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this type of device or this document.

The document indicates that the IT/IF Control is a quality control material used for the qualitative quality control of immunoelectrophoresis methods. Its purpose is to ensure the proper functioning of other diagnostic devices (e.g., SEBIA MINICAP, HYDRASYS instruments) when detecting and characterizing human monoclonal immunoglobulins.

Here's a breakdown of what can be extracted from the provided text, and where your questions are not applicable:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the IT/IF Control itself. For quality control materials, acceptance criteria would typically involve demonstrating that the material consistently produces expected results (e.g., specific electrophoretic patterns) when tested with the designated diagnostic instruments.
• Reported Device Performance: The document doesn't provide performance data in terms of sensitivity, specificity, accuracy, or similar metrics because it is a control material, not a diagnostic device. Its performance is implicitly linked to its ability to serve as a reliable control for the larger diagnostic systems.
  • What is mentioned: "The electrophoretic pattern obtained is specific for each batch of IT/IF control." This implies that consistency and specificity of the pattern are key performance characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This device is a quality control material. Studies involving "test sets" for diagnostic performance (like AI or imaging devices) are not typically conducted for control materials in the same way. The 510(k) application would have included validation data demonstrating the control's stability and consistency, but not a "test set" in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: "Ground truth" in the sense of expert consensus for diagnostic interpretation is not relevant for a quality control material. The "ground truth" for a control material is its known composition and expected behavior, which is established by the manufacturer through analytical testing and characterization.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are used in diagnostic studies to resolve discrepancies in expert interpretations. This is not pertinent to a quality control material.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: MRMC studies are for evaluating diagnostic systems (often imaging or AI-assisted systems) where human interpretation is involved. This device is a quality control material for laboratory instruments.

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

• Not Applicable: This device has no "algorithm" in the sense of an AI or diagnostic algorithm. It is a physical control material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of "Ground Truth": For a quality control material, the "ground truth" is its known, characterized chemical composition and established electrophoretic pattern. This is determined through rigorous analytical testing during manufacturing. The manufacturer would have established that the material contains specific IgG, IgA, IgM, Kappa, and Lambda components, and that these components consistently produce a predictable pattern when run on the specified instruments.

8. The sample size for the training set

• Not Applicable: "Training sets" are associated with machine learning and AI development. This product is a chemical control material.

9. How the ground truth for the training set was established

• Not Applicable: See point 8.

Summary regarding the IT/IF Control:

The IT/IF Control is a qualitative quality control material used in clinical laboratories. Its "performance" is about consistently providing a known and specific electrophoretic pattern when used with immunoelectrophoresis instruments. The 510(k) clearance indicates that the FDA deemed it substantially equivalent to existing control materials, meaning it is considered safe and effective for its intended purpose of ensuring the reliability of other diagnostic tests.

The information you are requesting is typically found in submissions for diagnostic medical devices, especially those involving imaging, AI, or direct diagnostic claims, rather than for ancillary quality control materials.

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