# K251579: VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 21, 2025 after 90 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: 4 generations back to K183524 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222073: VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL), bioMerieux, Inc. (2023) Summary page 5.

## Indications for use
VITEK 2 AST-Gram Negative Cefazolin is designed for antimicrobial susceptibility testing of Gram-negative bacilli and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST-Gram Negative Cefazolin (≤1-≥32 µg/mL) is a quantitative test. Testing is indicated for Enterobacterales (from infections other than uncomplicated UTI) as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). VITEK 2 AST-Gram Negative Cefazolin (≤1-≥32 µg/mL) has demonstrated acceptable performance with the following organisms: Enterobacterales (Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Klebsiella oxytoca, Citrobacter koseri) The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K251579
Methodology: https://510kreport.com/methodology