(a) Identification. A plazomicin test system is a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary tract infection.

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

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

(i) Precision study data that demonstrates clinically appropriate precision of the plazomicin test system. Precision studies must include a minimum of three samples containing different concentrations of plazomicin, including near medical decision points throughout the expected therapeutic range of plazomicin. Samples near the medical decision points must be clinical specimens collected from patients taking plazomicin.

(ii) Method comparison data that demonstrates clinically appropriate accuracy of the plazomicin test system, as determined by FDA. Method comparison data must be collected at a minimum of three laboratory sites.

(iii) Data from studies appropriate to demonstrate that the device is free from clinically significant interference from co-administered medications that are used in patients with complicated urinary tract infection, as determined by FDA.

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