# K020748: Etest Ertapenem

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Apr 29, 2002 after 53 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0822-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Apr 25, 2017 · Class II · Z-2095-2017: False susceptible results

## Indications for use
For in vitro diagnostic use: Etest is a quantitative technique for the 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, Pneumococcus, Streptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in pg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Ertapenem in the range of 0.002 - 32 pg/ml with E. coli. K. pneumoniae, 5. aureus (methicillin susceptible strains), S. pneumoniae (penicillin susceptible strains), 5. agalactiae, S. pyogenes, H. influenzae (§-lactamase negative strains), Bacteroides spp, Prevotella bivia, P. asaccharolytica and Peptostreptococcus spp.

Source page: https://510kreport.com/device/K020748
Methodology: https://510kreport.com/methodology