# K050075: Vitek 2 Gram Positive Daptomycin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 28, 2005 after 47 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032766 (2003). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032766: Vitek 2 Gram Positive Linezolid, bioMerieux, Inc. (2003) Summary page 1.

## Most influential descendants
- K072668: Vitek 2 Gram Positive Vancomycin (2007), 4 descendants of its own
- K091126: Vitek 2 Gram Positive Daptomycin (2009), 3 descendants of its own
- K230864: VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (2023), 1 descendant of its own
- K234000: VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (2024), 0 descendants of its own
- K093076: Vitek 2 Gram Positive Doxcycline (2010), 0 descendants of its own

## 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 the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITEK 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. VITEK 2 Gram Positive Daptomycin is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Source page: https://510kreport.com/device/K050075
Methodology: https://510kreport.com/methodology