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The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) clearance letter for the CAPILLARYS URINE device. It confirms that the device is substantially equivalent to a legally marketed predicate device but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about the test set.
• Information on experts, adjudication methods, or ground truth establishment for a test set.
• Details about multi-reader multi-case studies or standalone algorithm performance.
• Training set sample size or how its ground truth was established.

This document is a regulatory approval, not a scientific study report.

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The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the electrophoretic separation of proteins in human urine.

The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the immunologic identification of monoclonal components in human urine.

The PARAGON CZE® 2000 UPE and U-IFE/s kits are designed for optimal performance on the PARAGON CZE® 2000. The UPE kits contain one Segment package containing 20 Segments, five Desalting Column packages with 4 columns per package, and four 500 mL Desalting Reagent bottles. The U-IFE/s kits contain two Segment packages containing 10 Segments, one Desalting Column package with 4 columns per package, and one 500 mL Desalting Reagent bottle.

This document describes the acceptance criteria and supporting studies for the Beckman Coulter PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit and Urine Immunofixation By Subtraction (U-IFE/s) Kit.

Acceptance Criteria and Device Performance

The provided document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for a novel device. The performance data presented in Section 8.0 serves to show that the new devices perform comparably to their gel electrophoresis predicate counterparts.

Here's a table summarizing the performance data, which implicitly acts as evidence for meeting "acceptance criteria" of comparable performance to the predicate:

Study Information

The document describes studies conducted to demonstrate substantial equivalence of the new PARAGON CZE® 2000 UPE and U-IFE/s Kits to their respective predicate gel electrophoresis kits.

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

• UPE Kit Method Comparison:
  • Test Set Sample Size: 100 samples (indicated by 'n=100').
  • Data Provenance: Not explicitly stated, but clinical laboratory samples are generally assumed to be retrospective or a mix of prospective/retrospective from a specific clinical setting. Given the year 2005, it's highly likely to be retrospective samples from a clinical lab. No country of origin is specified.
• U-IFE/s Kit Method Comparison:
  • Test Set Sample Size: 82 samples (indicated by 'n=82').
  • Data Provenance: Not explicitly stated, but similar to the UPE kit, likely retrospective clinical samples. No country of origin is specified.
• UPE Imprecision Studies:
  • System Reproducibility: 21 runs for each urine pool (Albumin and BJP).
  • Desalting Reproducibility: 21 runs for each urine pool (Albumin and BJP).
  • Total Imprecision (EP 10-A): 15 runs for each of the three urine levels (Albumin and BJP).
  • Data Provenance: These are laboratory studies, likely conducted internally by the manufacturer. No country of origin is specified.
• U-IFE/s Reproducibility Studies:
  • Test Set Sample Size: Not explicitly stated as a number, but the description mentions "the replicate segments tested."
  • Data Provenance: These are laboratory studies, likely conducted internally by the manufacturer. No country of origin is specified.

3. Number of Experts and Qualifications for Establishing Ground Truth for the Test Set

The studies outlined (method comparison and imprecision) do not involve human expert consensus for "ground truth" in the way an imaging AI study would. Instead, the "ground truth" for the method comparison studies is established by the results from the predicate devices: the PARAGON Gel Electrophoresis – SPE Kit (for UPE) and the PARAGON Gel Electrophoresis – IFE Kit (for U-IFE/s).

• Number of Experts: Not applicable in the context of this type of IVD device study. The predicate device's results are considered the reference.
• Qualifications of Experts: Not applicable. The "ground truth" is derived from a previously cleared diagnostic method.

4. Adjudication Method for the Test Set

• Method Comparison Studies (UPE and U-IFE/s): The comparison method involves results from the new device being assessed against the predicate device. The results are categorized as "Agreement," "Partial Agreement," or "Disagreement" for UPE, and "Full Agreement" or "Disagreement" for U-IFE/s. It is implied that laboratory personnel or study investigators evaluated these agreements based on established protocols for comparing quantitative or qualitative results from two different methods. The specific adjudication method (e.g., 2+1, 3+1) is not specified as it's not a common paradigm for these types of IVD performance studies where instrument results are directly compared.
• Imprecision and Reproducibility Studies: These are quantitative measurements. Adjudication is statistical (e.g., calculation of Mean, SD, %C.V.). For U-IFE/s visual reproducibility, it states "electro-pherograms were visually inspected," but it doesn't specify if multiple readers were involved or an adjudication process for discrepancies.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is typically performed for AI/CADe (Computer-Aided Detection/Diagnosis) devices, especially in medical imaging. The devices in this submission (UPE and U-IFE/s Kits) are in vitro diagnostic kits that automate protein analysis, not an AI/CADe system for human interpretation enhancement. The comparison is between a new automated method (capillary electrophoresis) and an older automated/semi-automated method (gel electrophoresis).

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

Yes, the studies presented are essentially standalone performance evaluations of the devices. The "device performance" refers to the automated analysis performed by the PARAGON CZE® 2000 system using these kits. While a human operator initiates the test and interprets the final electropherograms (especially for U-IFE/s with visual inspection), the studies quantify the device's ability to perform the separation and detection reliably and accurately relative to a predicate, independent of variable human interpretation during the core analytical process.

7. The Type of Ground Truth Used

• For Method Comparison studies: The "ground truth" is implicitly the analytical result obtained from the predicate devices (PARAGON Gel Electrophoresis – SPE Kit for UPE, and PARAGON Gel Electrophoresis – IFE Kit for U-IFE/s).
• For Imprecision and Reproducibility studies: The ground truth is the expected performance within laboratory quality control parameters, with various urine pools (with known or characterized levels of Albumin and BJP) serving as reference samples.

8. The Sample Size for the Training Set

The document is a 510(k) submission for in vitro diagnostic kits, not an AI/machine learning device. Therefore, the concept of a "training set" for an algorithm, as understood in AI development, does not apply here. The kits are reagents and consumables for an existing analytical instrument (PARAGON CZE® 2000). The development of the methodology and reagents would have involved internal validation and optimization, but there isn't a "training set" in the sense of data used to train a predictive model.

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

As stated above, the concept of a "training set" for an algorithm is not applicable to the development and validation of these IVD kits. The "ground truth" in the development of such kits would involve:

• Analytical Chemistry Principles: The fundamental principles of capillary electrophoresis and immunofixation.
• Reference Materials: Using certified reference materials or well-characterized patient samples with known protein compositions/concentrations.
• Comparison to Established Methods: Extensive internal testing and optimization against existing, validated methods (like the predicate gel electrophoresis systems) to fine-tune reaction conditions, reagent formulations, and instrument parameters to achieve desired performance characteristics.

This information is derived from the provided 510(k) summary document.

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HYDRAGEL BENCE JONES, MAXI KIT HYDRAGEL BENCE JONES, HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies.

The analysis is generally performed on unconcentrated urine or on diluted serum. All these kits utilize the same composition of alkaline buffered HYDRAGEL BENCE JONES agarose gels and the same procedure which is carried out in two stages:

· electrophoresis of the sample on multi-track agarose gel to separate the individual urinary or serum proteins.

· the separated proteins in the reference track are fixed, the remaining tracks are subjected to respective immunofixation with anti aloha, gamma & mu heavy chain trivalent anti kappa and anti lambda free & bound light chains antisera; anti kappa and anti lambda free light chains antisera. The fixed and immunoprecipitated proteins are then stained with acid violet. The electrophoregrams are evaluated visually. The suspect band (in the reference track) is identified from the positive reaction, or lack of, with the individual antisera.

The HYDRAGEL BENCE JONES kit and MAXI KIT HYDRAGEL BENCE JONES are designed for use with a manual electrophoresis apparatus. The only difference between these two kits is the total number of tests which can be performed with i.e., 10 and 100, respectively. Each agarose gel in the HYDRAGEL BENCE JONES kit and MAXI-KIT HYDRAGEL BENCE JONES is intended to run one sample.

The HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus.

Each agarose gel in the HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits is intended to run two and four samples, respectively.

This document is an FDA 510(k) clearance letter for the HYDRAGEL BENCE JONES Kit. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, the document states that the device is "substantially equivalent" to predicate devices, which means it met the regulatory requirements for clearance based on comparison to existing devices, rather than necessarily performing a specific study to meet pre-defined acceptance criteria for a novel device.

Here's what is not present in the provided document:

1. A table of acceptance criteria and the reported device performance: This document only lists the indications for use and a general description of the test procedure. It doesn't present performance metrics like sensitivity, specificity, accuracy, or any specific numerical acceptance thresholds.
2. Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert review or ground truth establishment is provided.
4. Adjudication method for the test set: Not applicable as no test set or expert review is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This type of study is not mentioned. The device is a diagnostic kit, not an AI-assisted interpretation tool, so MRMC studies are generally not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a lab kit requiring human interpretation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
8. The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA clearance letter confirms the device's substantial equivalence to existing devices for its intended use, but it does not provide the kind of detailed study results and performance metrics that would be present in a clinical trial report or a more extensive submission for a novel device or an AI/ML product.

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