510(k) K212461

VITEK MS PRIME by bioMerieux, Inc. — Product Code QBN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 15, 2022
Date Received: August 6, 2021
Clearance Type: Traditional
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.

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K234012 — VITEK COMPACT PRO (March 14, 2025)
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K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus (October 23, 2023)
K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptom (July 5, 2023)
K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (June 26, 2023)

510(k) K212461

Clearance Details

Device Classification

Other clearances by bioMerieux, Inc.

Other clearances for product code QBN