510(k) DEN130013

VITEK MS by bioMerieux, Inc. — Product Code PEX

DEN130013 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VITEK MS". The FDA issued a decision of De Novo Granted on August 21, 2013. The device falls under product code PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates), a Class II device regulated under 21 CFR 866.3361. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: August 21, 2013
Date Received: January 2, 2013
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Device Class: Class II
Regulation Number: 866.3361
Review Panel: MI
Submission Type

A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

Other clearances by bioMerieux, Inc.

K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (July 8, 2026)
K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)
K234012 — VITEK COMPACT PRO (March 14, 2025)
K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)

510(k) DEN130013

Clearance Details

Device Classification

Other clearances by bioMerieux, Inc.

Other clearances for product code PEX

FDA data resources