Vitek 2 Systems (Pc) 5.02 Software

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K103752 ↗

FDA product code

LON

Device class

Class II

Regulation

21 CFR Part 866.1645

Advisory committee

Microbiology

FDA decision

SESE Substantially Equivalent

• ETEST® Gepotidacin (GEP)

  Class II

  FDA 510(k) K260447 Active Cleared 21 Apr 2026 GUDID on market

• ETEST® Aztreonam Avibactam (AZA)

  Class II

  FDA 510(k) K250856 Active Cleared 12 Jun 2025 GUDID on market

• VIDAS® Varicella-Zoster IgG 30217-01 Open recall

  Class II

  FDA 510(k) K923122 Active Cleared 26 Oct 1992 GUDID on market

• VITEK REVEAL SOFTWARE v1.3 CONTROL

  Class II

  CE/IVDR FDA 510(k) ×2 Active Cleared 20 Jun 2024 +1authorizations

• Vitek® 2 Ast-N816 Open recall

  Class II

  FDA 510(k) ×5 Active Cleared 19 Dec 2017 GUDID on market

• Columbia Sheep Blood Agar 5%

  Class I

  FDA 510(k) K830075 Active Cleared 9 Feb 1983

See all devices from Biomerieux, Inc. →

• What is the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE used for?

  The VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE is used for automated antimicrobial susceptibility testing with short incubation in clinical laboratory settings. It identifies microorganisms and determines their susceptibility to antibiotics, supporting microbiology workflows by reducing manual testing time and improving result consistency.

• How is the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE supplied and what is its intended use environment?

  The software is supplied as part of the VITEK 2 system and is intended for use in microbiology laboratories. It is designed to operate within clinical laboratory environments where automated identification and antimicrobial susceptibility testing are performed, supporting routine diagnostic workflows.

• Is the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE sterile, single-use, or MRI-safe?

  Based on the provided data, the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE is not indicated as sterile, single-use, or MRI-safe. It is a software component of a hardware system and does not possess physical properties requiring sterility or single-use designation; its safety regarding MRI environments is not addressed in the device data.

• What regulatory pathway was used for the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE and what is its classification?

  The VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE was cleared via the FDA 510(k) pathway under submission K103752 and is classified as a Class II medical device. The clearance type is traditional, and it was found substantially equivalent to a predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.

• What storage and handling considerations apply to the VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE?

  Storage and handling should follow the manufacturer's guidelines for software systems. As a software component, it requires appropriate environmental controls such as temperature, humidity, and protection from electromagnetic interference as specified by bioMerieux for the VITEK 2 system, though specific values are not detailed in the provided data.