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The Digoxin Immunoassay is intended for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria for the Digoxin Immunoassay.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the Digoxin Immunoassay: "for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information for clinical management of patients administered digoxin, aiding the physician in monitoring digoxin levels to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, or details of a specific study.
3. Details regarding number or qualifications of experts, or adjudication methods.
4. Information on MRMC comparative effectiveness studies.
5. Details on standalone algorithm performance.
6. The type of ground truth used.
7. Sample size for the training set or how ground truth for the training set was established.

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