# K021582: Bactec Mgit 960 Pza Kit

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 13, 2002 after 60 days
- Product code: MJA (Susceptibility Test Powders, Antimycobacterial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895362 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895362: Bactec Pyrazinamide Susceptibility Test, Bd Becton Dickinson Vacutainer Systems Preanalytic (1989) Summary page 4.

## Recalls of this device
- May 20, 2025 · Class II · Z-2023-2025: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
- Jul 18, 2024 · Class II · Z-2686-2024: May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

## Indications for use
The BACTEC MGIT 960 PZA Kit is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to pyrazinamide (PZA). The BACTEC MGIT 960 PZA Kit is used with the BACTEC MGIT 960 System. The BACTEC MGIT 960 PZA Kit final test concentration is 100 pg/mL for pyrazinamide.

Source page: https://510kreport.com/device/K021582
Methodology: https://510kreport.com/methodology