Vitek 2 System

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

E Coli Extension

Generic Name

Susceptibility test cards, antimicrobial

PMA Number

N50510 ↗

FDA Product Code

LTW

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S001

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  FDA 510(k) K920001 Active Cleared 25 Sep 1992

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  FDA 510(k) K935816 Active Cleared 22 Mar 1994

See all devices from Biomerieux Vitek, Inc. →

• What is the primary purpose of the Vitek 2 System in a clinical microbiology lab?

  The Vitek 2 System is designed for automated identification of bacteria and determination of antimicrobial resistance profiles. This helps clinicians quickly and accurately guide targeted antibiotic therapy by providing rapid results on which microbes are present and which antibiotics they are susceptible or resistant to.

• How is the Vitek 2 System supplied, and is it meant for single-use or reusable applications?

  The Vitek 2 System is supplied as a modular platform with integrated software, paired with antimicrobial susceptibility test cards. The test cards themselves are intended for single-use only, with sterility maintained through manufacturer-provided packaging to ensure contamination-free testing.

• What types of microorganisms can the Vitek 2 System identify and test for antimicrobial susceptibility?

  The Vitek 2 System is specifically designed for automated identification and antimicrobial susceptibility testing of microorganisms, though the exact range of supported bacteria is detailed in the manufacturer’s documentation. It is not intended for viral, fungal, or parasitic testing.

• How does the regulatory status of the Vitek 2 System affect its use in clinical settings?

  The Vitek 2 System is authorized under an FDA Premarket Approval (PMA) application (N50510), which means it has undergone rigorous review to ensure its safety and effectiveness for its intended use in clinical microbiology. This classification ensures compliance with regulatory standards for microbiological testing and supports its use in accredited laboratories.

• Are the test cards for the Vitek 2 System compatible with all bacterial strains, or are there specific limitations?

  The Vitek 2 System’s test cards are designed for a broad range of bacterial identification and susceptibility testing, but their compatibility depends on the specific card type and the manufacturer’s validated database. Laboratories should confirm compatibility with their local strains and consult the manufacturer’s guidelines to ensure accurate results.