Search Results

This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings

Not Found

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "Human C4 Kit for use on SPAPLUS™," indicating that the device is substantially equivalent to legally marketed predicate devices.

The document includes:

• Device Name: Human C4 Kit for use on SPAPLUS™
• Intended Use: For the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. To be used in conjunction with other laboratory and clinical findings.
• Regulatory Information: Regulation Number, Regulation Name, Regulatory Class, Product Code, and 510(k) Number.

However, it does not provide the following information requested in the prompt:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval notice, not a detailed study report describing performance characteristics against acceptance criteria.

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

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