(204 days)
EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.
Rapid Membrane ImmunoAssay
The provided document is a 510(k) premarket notification letter from the FDA for the EarlyDETECT® MENOPAUSE TEST. This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can, therefore, be marketed subject to general controls provisions. It specifies the device name, regulation number, regulation name, and product code, along with its intended use as a qualitative rapid membrane immunoassay for in vitro diagnostic detection of follicle-stimulating hormone (FSH) in human urine for confirming hormone changes related to menopause, intended for professional and Over-The-Counter (OTC) use.
Therefore, I cannot provide the requested information based on the text provided. A separate submission, often referred to as the 510(k) summary or the full 510(k) submission, would typically contain such detailed study information.
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(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.