(209 days)
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy.
The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.
CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility. CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
This is a Premarket Notification (510(k)) for the Clearplan Easy Fertility Monitor, indicating substantial equivalence to a predicate device. This document primarily focuses on regulatory approval and indications for use, without detailing specific performance studies or acceptance criteria for the device itself.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text. The document is a regulatory approval letter, not a detailed study report.
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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.