# K191766: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 5, 2019 after 35 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: 1 generation back to K183524 (2019). 1 ancestor in all.
7 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183524: VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL), bioMerieux, Inc. (2019) Summary page 4.

## Most influential descendants
- K213931: VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) (2022), 2 descendants of its own
- K222073: VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (2023), 1 descendant of its own
- K251579: VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (2025), 0 descendants of its own
- K222430: VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (2023), 0 descendants of its own
- K214023: VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) (2022), 0 descendants of its own

## Indications for use
VITEK® 2 AST-Gram Negative Eravacycline 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 Eravacycline is a quantitative test. Eravacycline 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 freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae In vitro data are available, but clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes 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/K191766
Methodology: https://510kreport.com/methodology