510(k) · Cleared
ClearedBD Probetec ET Mycobacterium Tuberculosis Complex (CTB) Culture Identification Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Biosciences · NDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Cleared on Jan 19, 2001 after a 305-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Jan 19, 2001
- Review
- 305 days
- Class
- Class I
- Product code
- NDZ
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NDZ devicesNDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDZ
FDA has decided no NDZ device since 2007.
Median 510(k) review, days · NDZ
Too few NDZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NDZ
No recall names NDZ since 2007.
Adverse event reports per year · NDZ
No MAUDE report names NDZ since 2007.
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 | — | 0 | 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 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000884: BD Probetec ET Mycobacterium Tuberculosis Complex (CTB) Culture Identification Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000884
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026