§ 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.

(a) Identification. A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

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

(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.

(2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols.

(3) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.

(4) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.

(5) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device.

[82 FR 49101, Oct. 24, 2017]