Cleared Traditional

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ?g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ?g/mL), VITEK 2 AST-YS Caspofungin

K213899 · bioMerieux, Inc. · Microbiology

Jul 2022

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K213899 is an FDA 510(k) clearance for the VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ?g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ?g/mL), VITEK 2 AST-YS Caspofungin, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 12, 2022, 210 days after receiving the submission on December 14, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K213899 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2021
Decision Date	July 12, 2022
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1645