# K121002: Etest Ceftaroline

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 12, 2012 after 193 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K102668 (2010). 1 ancestor in all.
11 later devices descend from it; 1 cites 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)
- K102668: Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML, Biomerieux (2010) Summary page 1.

## Most influential descendants
- K151873: Etest Ceftaroline (0.002 - 32ug/ml) (2015), 10 descendants of its own
- 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

## Recalls of this device
- Oct 16, 2014 · Class III · Z-0233-2015: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
- Oct 16, 2014 · Class III · Z-0230-2015: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
- Oct 16, 2014 · Class III · Z-0234-2015: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
- Oct 16, 2014 · Class III · Z-0231-2015: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
- Oct 16, 2014 · Class III · Z-0232-2015: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.

## 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. pneumnoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in pglmL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 - 32 pg/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent. Active in vitro and in clinical infections Skin Infections Staphylococdus aureus (including methicillin-susceptible and -resistant isolates)

Source page: https://510kreport.com/device/K121002
Methodology: https://510kreport.com/methodology