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The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assav

This appears to be a 510(k) premarket notification approval letter for a medical device (ACTH Immunoradiometric (IRMA) Assay) and not a study report. Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

Specifically, the document is an FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, or ground truth establishment for a test set.
• Information on expert adjudication or qualifications.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• Details on the sample size or ground truth for a training set.

The document only states the "Indications For Use" of the ACTH IRMA Assay.

Therefore, I cannot provide the requested information based on the input text.

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