(18 days)
VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta
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The provided text details the FDA clearance of "VITROS Immunodiagnostic Products Progesterone Reagent Pack" and "VITROS Immunodiagnostic Products Progesterone Calibrators" but does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed metrics requested in your prompt.
The document is an FDA 510(k) clearance letter, which confirms the substantial equivalence of the device to a legally marketed predicate device. It does not typically include the detailed performance data or study results.
Therefore, I cannot fulfill your request with the provided input. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, which would contain the performance study details.
§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(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.