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The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Optilite Freelite Kappa Free Kit and Optilite Freelite Lambda Free Kit:

Context: This submission is for a modification to a previously cleared device (K150658) to extend its indications for use to "aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS)". The core device technology and its principles (immunoturbidimetry for quantitative measurement of free light chains) remain unchanged. Therefore, the performance data provided specifically addresses the new MGUS claim.

Acceptance Criteria and Reported Device Performance

Device: Optilite® Freelite® Kappa Free Kit and Optilite® Freelite® Lambda Free Kit

Intended Use Extension: Aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS).

Study Details:

1. Sample Sizes and Data Provenance:

• Study 1 (Sensitivity and Specificity):
  • MGUS Samples (Sensitivity): 234 samples from patients with clinically confirmed MGUS.
  • Disease Controls (Specificity): 140 samples from patients with polyclonal hypergammaglobulinemia (non-MGUS).
  • Data Provenance: Retrospective testing of residual samples. The country of origin is not explicitly stated, but the company (The Binding Site Ltd.) is based in the United Kingdom.
• Study 2 (MGUS Progression):
  • Total Samples: 185 samples from 49 MGUS patients (45 stable, 4 progressive). Up to 4 individual sample draws for stable, up to 6 for progressive per patient.
  • Data Provenance: Retrospective testing of residual samples. Country of origin not explicitly stated.

2. Number of Experts and Qualifications for Ground Truth:

• The document states that the clinical diagnostic criteria that clinicians used to establish the "clinical truth" of MGUS positive samples were confirmed with each site.
• The ground truth for non-MGUS samples was based on "clinically confirmed polyclonal hypergammaglobulinemia" and "supporting clinical information."
• For the progression study, "clinically determined stable or progressive status" was the basis.
• The number of experts and their specific qualifications (e.g., radiologist with 10 years of experience) are not explicitly provided in the summary. It generally refers to "clinicians" and "clinical diagnosis."

3. Adjudication Method for the Test Set:

• Not explicitly mentioned. Given that the ground truth relies on "clinical diagnosis" and "clinically confirmed MGUS," it implies that the diagnostic criteria were applied by the treating clinicians at the respective sites prior to the retrospective study. There is no indication of an independent multi-expert adjudication process specifically for this study's test set.

4. MRMC Comparative Effectiveness Study:

• No. This submission is for an in-vitro diagnostic (IVD) device (a laboratory test), not an AI-assisted diagnostic tool that would directly assist human readers in image interpretation. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to measure improvement in human readers with AI assistance is not applicable and was not performed.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• Yes. The study evaluates the performance of the device (Optilite Freelite Kappa and Lambda Free Kits on the Optilite Analyser) in measuring FLC levels and deriving the kappa:lambda ratio. The performance metrics (sensitivity, specificity, categorization of stable/progressive) are reported for the device's output itself, compared to the clinical ground truth. This is a standalone performance assessment of the IVD test.

6. Type of Ground Truth Used:

• Clinical Diagnosis / Clinical Findings:
  • For MGUS positive samples: "clinically confirmed MGUS" based on diagnostic criteria, including those outlined by the 'International Myeloma Working Group (IMWG)' consensus.
  • For non-MGUS samples: "polyclonal hypergammaglobulinemia confirmed by study testing (total IgG/lgA/lgM and serum IFE), with supporting clinical information."
  • For stable/progressive MGUS: "clinically determined stable or progressive status" based on patient follow-up and conversion to MM or stable status over time. This includes evaluation criteria based on IMWG guidelines for multiple myeloma regarding FLC changes.

7. Sample Size for the Training Set:

• Not applicable. This submission focuses on the performance of a lab-based immunoassay kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The test method is immunoturbidimetry, which relies on chemical reactions and optical detection, not an algorithm that learns from data.

8. How Ground Truth for the Training Set Was Established:

• Not applicable, as there is no "training set" for this type of device. The method is a validated laboratory assay.

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This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Human IgM Kit for use on the SPAPLUS™". This document confirms that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain the detailed study information, acceptance criteria, or performance data that you have requested in your prompt. A 510(k) clearance letter typically does not include the specifics of the underlying studies that prove the device meets acceptance criteria. That information would usually be found in the 510(k) submission itself or in accompanying technical documentation, which is not provided here.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text.

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This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPIJS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Human IgA liquid reagent kit for use on SPAPLUS™

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device, the "Human IgA Liquid Reagent Kit for use on SPAPLUS™". This type of document declares a device substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance. Specifically, the document is a regulatory approval letter and does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test or training sets.
• Details on data provenance.
• The number or qualifications of experts used for ground truth establishment.
• Adjudication methods.
• Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• The type of ground truth used.
• How ground truth was established for training data.

Therefore, I cannot fulfill the request using only the provided input. This document simply states that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies that underpinned this determination.

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These assays are designed for the in-vitro measurement of specific IgG or IgA antibodies against a modified gliadin peptide (MGP) in human serum, as an aid in the diagnosis of coeliac disease in conjunction with other clinical and laboratory findings.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is an FDA 510(k) clearance letter for the BINDAZYME™ Human Anti-Gliadin (MGP) IgG/IgA EIA Kits, which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not include:

• A table of acceptance criteria and reported device performance.
• Information about specific studies conducted to prove the device meets acceptance criteria.
• Details on sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either test or training sets.

This type of information is typically found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter provided. The clearance letter is merely the FDA's decision based on its review of that submission.

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This Cystatin C kit is intended for the quantitative determination of Cystatin C in human serum, lithium heparin, plasma and EDTA plasma by turbidimetry using the Roche Modular P analyser. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases in conjunction with other laboratory and clinical findings.

Human Cystatin C kit For Use on the Modular P

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Human Cystatin C kit For Use on the Modular P." This document primarily focuses on regulatory approval and does not contain detailed information regarding the acceptance criteria, study design, or performance metrics of the device as requested in the prompt.

Therefore, it is not possible to provide the requested information based solely on the provided text. The document confirms market clearance based on substantial equivalence to a predicate device, but it does not describe the specific studies or performance data used to support that claim beyond what is typically presented in a 510(k) summary (which is not fully included here).

To fulfill the request, a more comprehensive document, such as the 510(k) summary or the full submission, would be required.

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For the quantitation of kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.

For the quantitation of lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.

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This FDA 510(k) clearance letter dated November 30, 2007, for the "FREELITE™ Human Lambda Free Kit for use on Roche COBAS® INTEGRA 400/400 plus" and "FREELITE™ Human Kappa Free Kit for use on Roche COBAS® INTEGRA 400/400 plus" focuses on establishing substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain the specific acceptance criteria or detailed study results that demonstrate the device meets those criteria.

The letter confirms that the device is substantially equivalent for the stated indications for use (quantitation of kappa and lambda free light chains in serum to aid in the diagnosis and monitoring of various conditions). However, it does not provide the technical performance data, test methods, or statistical analyses typically found in a study report.

Therefore, I cannot populate the requested table or answer the specific questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies based solely on the provided FDA clearance letter. These details would be contained within the 510(k) submission itself, which is not included here.

To answer your request, I would need access to the full 510(k) submission document, specifically the sections detailing the validation and verification studies.

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This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.

This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.

Not Found

I am sorry, but the provided document does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, or details of any studies (like MRMC or standalone studies). The document is an FDA 510(k) clearance letter for two kits (FREELITE Human Kappa Free Kit and FREELITE Human Lambda Free Kit) and their indications for use, but it does not include the technical study details requested.

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