(27 days)
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.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.