(a) Identification. An anti-mullerian hormone test system is an in vitro diagnostic device intended to measure anti-mullerian hormone in human serum and plasma. An anti-mullerian hormone test system is intended to be used for assessing ovarian reserve in women.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include:

(i) An adequate traceability plan to minimize the risk of drift in anti-mullerian hormone test system results over time.

(ii) Detailed documentation of a prospective 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 adequate clinical performance relative to a well-accepted comparator.

(B) Clinical sample results must demonstrate consistency of device output throughout the device measuring range that is appropriate for the intended use population.

(C) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the proposed indications for use(s), and results of all statistical analyses.

(iii) Reference intervals generated by testing an adequate number of samples from apparently healthy normal individuals in the intended use population.

(2) The labeling required under § 809.10(b) of this chapter must include a warning statement that the device is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy, and that the device should be used in conjunction with the antral follicle count.