(a) Identification. A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy.

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

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

(i) Data demonstrating the precision of the voriconazole test system. Precision studies must include a minimum of three samples containing different concentrations of voriconazole, including near medical decision points at the high and low end of the expected therapeutic range. Samples with concentrations near medical decision points must be individual or pooled clinical specimens, collected from patients taking voriconazole.

(ii) Method comparison data demonstrating accuracy of the voriconazole test system. Method comparison data must be collected at three laboratory sites. The comparator method must not be subject to bias due to nonspecific detection of voriconazole.

(iii) Data from interference studies performed to evaluate potential interference from co-administered medications used for conditions in which voriconazole is indicated.

(iv) Data from studies performed to evaluate cross reactivity of the major metabolite, N-oxide voriconazole.

(2) The labeling required under § 809.10(b) of this chapter must include a warning statement as follows: “This assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures.”