(59 days)
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, and the ectopic ACTH syndrome.
ACTH Immunoradiometric (IRMA) Assay
The provided document is a 510(k) clearance letter from the FDA for a device called "ACTH Immunoradiometic (IRMA) Assay" manufactured by Scantibodies Laboratory, Inc. This letter primarily confirms the substantial equivalence of the device to legally marketed predicate devices.
However, the document does not contain the specific acceptance criteria, study details, or performance data that would typically be found in a study report or a more detailed submission. It states that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. The information provided is primarily administrative and regulatory.
Therefore, based solely on the provided text, I cannot generate the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because that specific data is not present in this regulatory clearance letter.
To provide the requested information, a different document, such as a summary of safety and effectiveness, the 510(k) submission itself, or a published study report, would be needed.
§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. 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.(b)
Classification. Class II.