Search Results

Ask a specific question about this device

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

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.

Ask a specific question about this device

This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.

Not Found

This is a 510(k) premarket notification letter for the FARRZYME Human High Avidity Anti-dsDNA Enzyme Immunoassay Kit. The document does not contain the detailed acceptance criteria and study information you requested. It primarily focuses on the FDA's substantial equivalence determination.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device