# K040845: Vitek 2 Esbl Test

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 8, 2004 after 68 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100, Shimadzu Medical Systems (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0837-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Nov 9, 2022 · Class II · Z-0833-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. The VITEK® 2 ESBL Test is a confirmatory test used to detect the presence of extended-spectrum beta-lactamases (ESBLs) in Escherichia coli, Klebsiella pneumoniae, and K. oxytoca. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The VITEK 2 ESBL test contains the following antimicrobial concentrations: Cefepime 1.0 pg/ml Cefepime/Clavulanic Acid 1.0/10 pg/ml Cefotaxime 0.5 pg/ml Cefotaxime/Clavulanic Acid 0.5 /4.0 pg/ml Ceftazidime 0.5 pg/ml Ceftazidime/Clavulanic Acid 0.5 / 4.0 pg/ml

Source page: https://510kreport.com/device/K040845
Methodology: https://510kreport.com/methodology