510(k) DEN170081

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

April 20, 2018

Date Received

September 29, 2017

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Device Class

Class II

Regulation Number

866.3378

Review Panel

MI

Submission Type

The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.