# K102668: Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux
- Decided: Nov 17, 2010 after 62 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121002: Etest Ceftaroline (2012), 11 descendants of its own
- 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

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0830-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Dec 15, 2016 · Class II · Z-1531-2017: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

## Indications for use
This submission is for Etest®Tobramycin for MIC determinations across 0.016-256 ptg/mL and 0.064-1024 Iig/mL with Staphylot-acms aurrus, Enterobaciediaceaeand P. aerztginosa. Etest®1 is a cquantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as En/erobasaerzaceae, IRseudomonaj, Slaphylo toxns and En/erotocats species and fastidious bacteria, such as anacrobes, N. ,gonotrhoeae, S. pneunoniae, Sftrp/otoczus and Haernophiluj species. The system comprises a predefined antibiotic gradient which is used to determine the NMinmum Inhibitory Concentration (MIC) in pg/mE of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.

Source page: https://510kreport.com/device/K102668
Methodology: https://510kreport.com/methodology