# K151873: Etest Ceftaroline (0.002 - 32ug/ml)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Oct 7, 2015 after 90 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 K102668 (2010). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121002: Etest Ceftaroline, bioMerieux, Inc. (2012) Summary page 4.

## Most influential descendants
- K180936: ETEST Telavancin (TLA) (0.002-32 ug/mL) (2018), 5 descendants of its own
- K170670: Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) (2017), 3 descendants of its own
- K192050: ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) (2019), 2 descendants of its own
- K172150: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (2017), 2 descendants of its own
- K210757: ETEST Fosfomycin (FO) (0.032-512 µg/mL) (2021), 1 descendant of its own

## Indications for use
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in μg/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. This submission is for additional indications for the antimicrobial Etest® Ceftaroline at concentrations of 0.002 – 32 μg/mL. Etest® Ceftaroline has been shown to be active in vitro against fastidious strains of the microorganisms listed below, according to the FDA label for this antimicrobial agent: Streptococcus pneumoniae, Streptococcus agalactiae, Haemophilus influenzae.

Source page: https://510kreport.com/device/K151873
Methodology: https://510kreport.com/methodology