# K031410: Vitek 2 Gram Positive Linezolid for Streptococcus Pneumoniae

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 10, 2003 after 66 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
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
- K020510: Smoke Evacuation Hoses/Tubing, Dm Medical, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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/K031410
Methodology: https://510kreport.com/methodology