# K053097: Vitek 2 Gram Positive Cefoxitin Screen

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 14, 2005 after 41 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has 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
- K051113: Quanta System Etrna Giovinezza, Quanta System Spa (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K080201: Vitek 2 Gram Positive Inducible Clindamycin Resistance (2008), 3 descendants of its own
- K111909: Vitek 2 Streptococcus Inducible Clindamycin Resistance (2011), 2 descendants of its own
- K260282: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (2026), 0 descendants of its own
- K220805: VITEK 2 AST-Gram Positive Cefoxitin Screen (2022), 0 descendants of its own
- K181766: VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance (2018), 0 descendants of its own

## Recalls of this device
- Mar 11, 2020 · Class II · Z-1742-2020: There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
- Jan 26, 2018 · Class I · Z-2817-2018: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

## Indications for use
VITEK® 2 Gram Positive Cefoxitin Screen is a qualitative test designed to predict mecA-mediated resistance in staphylococci. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems 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.

Source page: https://510kreport.com/device/K053097
Methodology: https://510kreport.com/methodology