Bactec Mgit 960 Pza Kit

• • Ongoing Z-2023-2025 FDA Class II ·initiated 20 May 2025

  BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

• • Ongoing Z-2686-2024 FDA Class II ·initiated 18 Jul 2024

  May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

510(k) Number

K021582 ↗

FDA Product Code

MJA

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the BACTEC MGIT 960 PZA Kit used for?

  The BACTEC MGIT 960 PZA Kit is designed specifically for qualitative susceptibility testing of *Mycobacterium tuberculosis* to pyrazinamide (PZA). It helps microbiology laboratories determine whether the bacteria are resistant to PZA, which is critical for guiding targeted and effective treatment plans. This information supports clinical decisions by identifying strains that may require alternative or additional therapies.

• Is the BACTEC MGIT 960 PZA Kit sterile?

  No, the BACTEC MGIT 960 PZA Kit is not sterile. It is intended for use with sterile culture media and patient samples within the BD BACTEC MGIT 960 System. The kit itself is a single-use reagent, and proper aseptic techniques must be followed when handling it to ensure reliable test results.

• How is the BACTEC MGIT 960 PZA Kit supplied and used?

  The kit is supplied as a single-use reagent, meaning each kit is intended for one test cycle. It is not reusable and must be used within the BD BACTEC MGIT 960 automated system, which handles culture and susceptibility testing for mycobacteria. The kit is designed for clinical microbiology laboratories and requires qualified personnel to perform testing following established protocols.

• Can the BACTEC MGIT 960 PZA Kit be reused?

  No, the BACTEC MGIT 960 PZA Kit is explicitly designed for single-use only. Reusing the kit could compromise test accuracy and introduce contamination risks, potentially leading to unreliable susceptibility results. Always follow the manufacturer’s guidelines for proper disposal after use.

• What regulatory pathway does the BACTEC MGIT 960 PZA Kit follow?

  The BACTEC MGIT 960 PZA Kit is regulated under the FDA 510(k) clearance pathway as a Class II medical device, with clearance number K021582. It falls under regulatory category 866.1640 for susceptibility test powders and is classified as substantially equivalent to a predicate device. This ensures it meets microbiology standards for antimycobacterial testing.