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The N-Assay TIA C3 Test Kit is intended to be used for the quantitation of C3 in human serum by immunoturbidimetric assay. The measurement of C3 aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

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The provided document is a 510(k) clearance letter from the FDA for the "N-Assay TIA C3 Test Kit." This type of document primarily confirms that a new medical device is substantially equivalent to a previously marketed device (predicate device) and can therefore be marketed.

It describes the intended use of the device: "The N-Assay TIA C3 Test Kit is intended to be used for the quantitation of C3 in human serum by immunoturbidimetric assay. The measurement of C3 aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components."

However, this document does not contain any information regarding acceptance criteria, study details, reported device performance, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, not in the FDA's clearance letter. The letter only states that the device has been reviewed and found substantially equivalent.

Therefore, I cannot populate the requested table and answer the questions based on the provided text.

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The N-Assay TIA Alpha-l-Acid Glycoprotein Test Kit is intended for the quantification of human alpha-l-acid glycoprotein in human serum by immunoturbidimetric assay. Measurement of alpha 1acid glycoprotein may aid in the diagnosis of collagen ( connective tissue ) disorders, tuberculosis, infections, extensive malignancy and diabetes.

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This document is a 510(k) clearance letter from the FDA for a medical device (N-Assay TIA Alpha-1-Acid Glycoprotein Test Kit) and does not provide detailed information on acceptance criteria or the specific study details that would typically be found in a study report or clinical trial summary.

Therefore, most of the requested information cannot be extracted from the provided text.

However, based on the limited information, here's what can be stated:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document is a regulatory clearance, not a performance report.

2. Sample size used for the test set and the data provenance: Not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.

4. Adjudication method: Not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available in the provided text. This type of study is more common for imaging diagnostics, whereas this device is a laboratory test kit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an "immunoturbidimetric assay" test kit, implying an automated or semi-automated process for quantification. Its performance would be evaluated in a standalone manner, but the details of such a study are not provided.

7. The type of ground truth used: For an immunoturbidimetric assay, the "ground truth" for a performance study would typically be established against a reference method or another validated laboratory assay, measuring the actual concentration of alpha-1-acid glycoprotein. The document does not specify the method used to establish ground truth in any study.

8. The sample size for the training set: Not applicable/not available. This device is a diagnostic test kit, not an AI/machine learning algorithm that typically requires a 'training set.'

9. How the ground truth for the training set was established: Not applicable/not available.

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The N-Assay TIA Multi V-NL Calibrator is intended to be used to calibrate the Crestat N-Assay TIA test Kits used To Carrorate the Orosas av C4 Test Kit, N-Assay Transferrin Test Kit, N-Assay Haptoglobin Test Kit, N-A66ay Alphael-Acid Glycoprotein Test Kit. The test kits are to be run on human serum.

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This document is a marketing approval letter from the FDA for a medical device (N-Assay TIA Multi V-NL Calibrator). It confirms that the device is substantially equivalent to previously marketed devices and can be sold. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based solely on the text provided. This document is a regulatory approval, not a scientific study report.

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The N-Assay TIA Haptoglobin Test Kit is intended to be used for the quantitation of haptoglobin in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

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I'm sorry, but this document does not contain the information needed to create the requested response. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "N-Assay TIA Multi V-NL." It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory information.

However, it does not include any details about:

• Acceptance criteria for the device's performance
• A study that proves the device meets acceptance criteria
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case studies or effect sizes
• Standalone algorithm performance
• Type of ground truth used or how it was established

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

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