# K193299: VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 28, 2020 after 306 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 5.

## Indications for use
VITEK® 2 AST-Gram Negative Ceftazidime 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 Ceftazidime is a quantitative test. Ceftazidime 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: Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species In vitro data are available, but clinical significance is unknown: Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica 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/K193299
Methodology: https://510kreport.com/methodology