(a) Identification. A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.

(b) Classification. Class II (special controls). A menopause test system must comply with the following special controls:

(1) Design verification and validation must include the following:

(i) An appropriate traceability plan to minimize the risk of drift in the menopause test system results over time.

(ii) Detailed documentation of a clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:

(A) Results must demonstrate appropriate clinical performance relative to a well-accepted and appropriate comparator.

(B) Data must demonstrate accuracy of device output for each indicated specimen type throughout the device measuring range as appropriate for the intended use population.

(2) The labeling required under § 809.10 of this chapter must include the following:

(i) A statement in the indications for use that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions.

(ii) A limiting statement that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions.

(iii) A limiting statement appropriately describing the risks of false test results and that test results should not be relied upon in clinical decision making (e.g., to discontinue contraceptive use and/or to evaluate patients for the presence of endometrial cancer) without other clinical and laboratory findings.