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The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha DX Analyzer. The Alpha DX Cardiac Panel Test Kits are fluorescence Immunoassay Analyzer for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.

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I am sorry, but based on the provided text, I cannot provide a comprehensive description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the "Alpha DX System," and it primarily concerns the regulatory approval process rather than detailed performance data or study results.

The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It mentions the "Alpha Dx Cardiac Panel Test Kit" for the rapid measurement of myoglobin, CK, CK-MB, and Tnl with the Alpha DX Analyzer, but it does not include the following crucial information for your request:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm-only performance study.
• Type of ground truth used (e.g., pathology, outcomes).
• Sample size for the training set.
• How ground truth for the training set was established.

To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the detailed study protocols, results, and justification for the substantial equivalence claim. The provided FDA letter is merely the official notification of market clearance.

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The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer. The analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.

The Alpha Dx Analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Alpha Dx System" from 2001, indicating substantial equivalence to predicate devices but does not include:

• Specific acceptance criteria values (e.g., sensitivity, specificity, accuracy thresholds).
• Reported device performance data (e.g., actual sensitivity, specificity, accuracy values).
• Details about the study design, sample sizes (test or training set), data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
• Information on standalone performance or the type of ground truth used in studies.

The document primarily focuses on regulatory clearance based on substantial equivalence, not a detailed performance study report.

Therefore, I cannot provide the requested table and detailed answers based solely on the input text.

Ask a specific question about this device