(157 days)
THE BIO-RAD MICROPLATE 17- HYDROXYPROGESTERONE (17-OHP) TEST IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF ιτα HYDROXYPROGESTERONE IN DRIED BLOOD SPOTS IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE AS AN ALD IN SCREENING NEWBORNS FOR CONGENITAL, ADRENAL HYPERPLASIA.
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This document is a marketing authorization letter from the FDA for a medical device called "Microplate 17-Hydroxyprogesterone Test". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain any information about the acceptance criteria, study details, or performance data of the device. It is purely a regulatory approval document.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as that information is not present in the provided text.
§ 862.1395 17-Hydroxyprogesterone test system.
(a)
Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.