# K141149: Vitek 2 Ast GP Ceftaroline

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 20, 2014 after 46 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 K032766 (2003). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122547: Gram Postitve Clindamycin, bioMerieux, Inc. (2012) Summary page 1.

## Most influential descendants
- K190616: VITEK 2 AST-Gram Positive Dalbavancin (<=  0.015 - >= 1 µg/mL) (2019), 3 descendants of its own
- K212243: VITEK 2 AST- Gram Positive Telavancin (<=0.015 -  >=1 µg/mL) (2022), 0 descendants of its own
- K202396: VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (2021), 0 descendants of its own
- K200590: VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (2020), 0 descendants of its own

## Indications for use
VITEK® 2 Gram Positive Ceftaroline is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Gram Positive Ceftaroline is a quantitative test. Ceftaroline 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 Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K141149
Methodology: https://510kreport.com/methodology