510(k) · Cleared
Recalled · Class II · 2025Bactec Mgit 960 Pza Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · MJA Susceptibility Test Powders, Antimycobacterial
Cleared on Jul 13, 2002 as substantially equivalent to K895362 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1989) after a 60-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 2 times.
- Decided
- Jul 13, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- MJA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895362 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895362 Bactec Pyrazinamide Susceptibility TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1989
- This deviceK021582 Bactec Mgit 960 Pza KitBecton, Dickinson & CO · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895362 | Bactec Pyrazinamide Susceptibility Test | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989 | — |
| 0 (this device) | K021582 | Bactec Mgit 960 Pza Kit | Becton, Dickinson & CO | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MJA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895362 | Bactec Pyrazinamide Susceptibility TestSummary page 4…trate that the BACTEC@MGITTM960 PZA susceptibility test, used with the BACTEC@MGITTM960 System, is substantially equivalent’ to the BACTEC@460TB PZA susceptibility test (K895362). 1 The term “substantial equivalence” as used in this 51O(k) notification is limited to the definition of substantial equi… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2025 | Class II | Z-2023-2025 | Under Investigation by firm | 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 | Under Investigation by firm | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K895362.
How does its category compare?
All MJA devicesMJA Susceptibility Test Powders, Antimycobacterial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJA
FDA has decided no MJA device since 2007.
Median 510(k) review, days · MJA
Too few MJA 510(k)s in any year since 2007 to give a median.
Recalls per year · MJA
4in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJA
529in 2025
MAUDE reports naming product code MJA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 4 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 43 |
| 2024 | 0 | — | 0 | 164 |
| 2025 | 0 | — | 0 | 529 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021582: Bactec Mgit 960 Pza Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021582
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026