# K222073: VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 9, 2023 after 210 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: 3 generations back to K183524 (2019). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213931: VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL), bioMerieux, Inc. (2022) Summary page 4.

## Most influential descendants
- K251579: VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (2025), 0 descendants of its own

## 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 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Cefazolin is a quantitative test. Cefazolin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Escherichia coli Proteus mirabilis 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/K222073
Methodology: https://510kreport.com/methodology