# K103752: Vitek 2 Systems (PC) 5.02 Software

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 14, 2011 after 295 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: 5 generations back to K032788 (2003). 5 ancestors in all.
19 later devices descend from it; 2 cite it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091899: Vitek 2 Gram Negative Meropenem, bioMerieux, Inc. (2009) Summary page 1.

## Most influential descendants
- K121546: Vitek 2 Gram Negative Doxycycline (2012), 15 descendants of its own
- K161227: VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (2016), 5 descendants of its own
- K172731: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (2017), 3 descendants of its own
- K220546: Colibrí System (2022), 2 descendants of its own
- K183415: VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (2019), 2 descendants of its own

## Indications for use
VITEKO 2 ON Imipenem is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 ON Imipenem is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems using VITEK 2 Systems 5.02 Software as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Imipenem has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Morganella morganhi Citrobacter spp. Proteus vulgaris Enterobacter aerogenes Providencia retigeri Eacherichia coli Pseudomonas aeruginosa Kiebsiella spp. Serratia marcescens Active in vitro but clinical significance unknown: Providencia stuarii 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 app., Enterococcus app., Streptococcus agalactiae, S. pneurnoniae and clinically significant yeast. The VITEK 2 Systems (PC) 5.02 Software is intended for use with VITEK 2 and VITEK 2 Compact Systems.

Source page: https://510kreport.com/device/K103752
Methodology: https://510kreport.com/methodology