# K213931: VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 3, 2022 after 169 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- 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

## Indications for use
VITEK® 2 AST-Gram Negative Omadacycline 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 Omadacycline is a quantitative test. Omadacycline 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: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Enterobacter cloacae Klebsiella pneumoniae For Community Acquired Bacterial Pneumonia (CABP): Klebsiella pneumoniae 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/K213931
Methodology: https://510kreport.com/methodology