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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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mis kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis. mese tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.

SPIFETM Electrophoresis System

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested. The document is an FDA 510(k) clearance letter for the SPIFE™ Electrophoresis System, which indicates that the device has been found substantially equivalent to a predicate device.

The letter does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, nor data provenance.
3. Information about experts, ground truth establishment, or adjudication methods.
4. Details on multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided input.

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These kits are intended for separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer.

This test can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias and genetic deficiencies.

Not Found

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a device, the REP SPE Vis-60/40 Kit, and does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to a pre-amendments device and can be marketed.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The 510(k) letter confirms the device's regulatory pathway and its intended use for "separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer" to assist in diagnosing various disease states. However, it does not include the detailed performance study information you are asking for.

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Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for the separation and measurement of protein fractions in human serum when used with the Bio-Rad BioFocus Capillary Electrophoresis Unit.

The Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for use on the Bio-Rad BioFocus Capillary Electrophoresis Unit. The analytical system, consisting of instrument, CDM software and reagent kit, provides an assay for the separation and percent determination of protein fractions in human serum.

Like the Paragon CZE™ 2000 Clinical Capillary Electrophoresis System, Beckman Instruments, (K953077), the Bio-Rad Serum Proteins by Capillary Electrophoresis "Serum Proteins by CE" (SPCE) utilizes the principle of capillary fraction electrophoresis to separate human serum proteins into five distinct bands. The separation is performed at a pH above the isoelectric point of serum proteins, imparting a net negative charge to each protein that is dependent on the difference between the separation pH and the individual protein isoelectric point. When an electric field is applied across the ends of the capillary, the negatively charged proteins and internal marker migrate toward the anode at a velocity dependent upon the ratio of mass to charge. At this pH, the internal surface of the silica capillary is highly ionized, and the presence of positively charged ions in the separation buffer results in a bulk flow of fluid towards the cathode. This electroosmotic flow (EOF) runs counter to the direction of protein migration and is stronger than the anodic movement of the proteins. As a result, the proteins' net motion is towards the detection zone near the cathodic end of the capillary. Measurement of protein absorbance at 225 nm is then achieved through a transparent section of the silica capillary.

Sample processing consists of a one step dilution of a senum sample with a diluent containing an internal marker. The prepared samples, up to 28, are then placed into the BioFocus for analysis.

A Reference Sample is included as the first sample analyzed in each tray to verify system performance. Proteins are measured, as they exit the cathodic end of the capillary, by direct absorbance of the peotide bond at 225 nm. The Clinical Data Management System (CDM), (K942451), utilizes the time versus signal data along with the internal marker, which is used to convert migration time to electrophoretic mobility, to quantitate the percentage of each of the five protein fractions.

Here's a breakdown of the acceptance criteria and study details for the Bio-Rad Serum Proteins by Capillary Electrophoresis device based on the provided document:

Acceptance Criteria and Device Performance

The general acceptance criteria for this device appear to be tied to demonstrating substantial equivalence to existing predicate devices, specifically the Beckman Paragon SPE kit and the Paragon CZE™ 2000 Clinical Capillary Electrophoresis System. The direct performance metrics evaluated were precision and accuracy (correlation).

Study Details

The Bio-Rad Serum Proteins by Capillary Electrophoresis device was studied to establish its safety and effectiveness by demonstrating substantial equivalence to predicate devices.

1. Sample size used for the test set and the data provenance:

   • Precision Studies: 20 samples each of normal and abnormal control were analyzed for mean area percent.
   • Correlation Study (Accuracy): The document does not explicitly state the sample size for the correlation study beyond "The correlation study... followed NCCLS Document EP9-T."
   • Data Provenance: Not explicitly stated, but given the context of a 510(k) submission to the FDA, it is prospective data collected for the purpose of regulatory approval and is likely from a clinical laboratory setting. The country of origin is not specified, but the submitting company is based in California, USA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The "ground truth" for the precision study would be the direct measurements of the samples, and for the correlation study, it would be the results from the predicate device. There is no mention of independent experts establishing ground truth in the traditional sense of diagnostic image/data interpretation.

3. Adjudication method for the test set:

   • Not applicable as this study is evaluating quantitative measurements against a predicate device, rather than subjective interpretations requiring adjudication.

4. 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:

   • No, a MRMC study was not conducted. This device is an automated analytical system, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, the performance described (precision, measuring range, and accuracy) represents the standalone performance of the Bio-Rad Serum Proteins by Capillary Electrophoresis system, which includes the instrument and software for analysis. This is an "algorithm only" type of performance as it's an automated measurement system.

6. The type of ground truth used:

   • For precision, the ground truth is essentially the inherent quantitative measurement of the device itself (reproducibility across multiple runs).
   • For accuracy (correlation), the ground truth was the results obtained from the predicate device, the Beckman Paragon Gel Electrophoresis kit.

7. The sample size for the training set:

   • This document describes performance evaluation studies (test set), not the development or training of an algorithm. Therefore, "training set" information is not applicable and not provided.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a training set for an AI algorithm.

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Ask a specific question about this device