# K201675: VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 9, 2021 after 385 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K183524 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191766: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL), bioMerieux, Inc. (2019) Summary page 4.

## Indications for use
VITEK® 2 AST-Gram Negative Meroepnem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data are available, but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens The VITEK® 2 Gram-Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms listed on the FDA Susceptibility Test Interpretive Criteria website: Acinetobacter spp. The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K201675
Methodology: https://510kreport.com/methodology