Cleared Traditional

K230864 - VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (FDA 510(k) Clearance)

K230864 · bioMerieux, Inc. · Microbiology device

Jul 2023

Decision

98d

Days

Class 2

Risk

K230864 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin. This device is classified as 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 5, 2023, 98 days after receiving the submission on March 29, 2023.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K230864 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 2023
Decision Date	July 05, 2023
Days to Decision	98 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