510(k) · Cleared
Recalled · Class II · 2025BD Max Cdiff Assay, BD Max Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geneohm Sciences Canada, Inc. (Bd Diagnostics) · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Apr 2, 2013 as substantially equivalent to K081920 (Bd Diagnostics (Geneohm Sciences, Inc.), 2008) after a 36-day review. Its family tree reaches back 2 generations to 1993. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 2, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- OZN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923463 (1993). 3 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 1 generation backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- This deviceK130470 BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013
- Descendant · cites it directly · 5 of its ownK142422 cobas Cdiff TestRoche Molecular Systems, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK171770 cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK212427 cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK172569 GenePOC CDiffGenepoc, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK260045 cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System…Roche Molecular Systems, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142422cobas Cdiff TestRoche Molecular Systems, Inc. · 2015 · cites it directly5descendants
- K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017 · 2 generations on4descendants
- K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2021 · 3 generations on2descendants
- K172569GenePOC CDiffGenepoc, Inc. · 2017 · cites it directly1descendant
- K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…Roche Molecular Systems, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −1 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| 0 (this device) | K130470 | BD Max Cdiff Assay, BD Max Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013 | — |
| +1 | K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015 | — |
| +2 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2017 | — |
| +3 | K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021 | — |
| +1 | K172569 | GenePOC CDiff | Genepoc, Inc. | 2017 | 1 |
| +4 | K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System… | Roche Molecular Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 OZN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OZN device
- #1 K260045 cobas® Cdiff Nucleic acid test for use on the…score 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K081920 | BD Geneohm Cdiff AssaySummary page 1…QZN, 001 Panel: Microbiology (83) Predicate Device: BID Geneohm TM Cdiff Assay Predicate 510(k) number: K081920 Intended Use: The BID MAX TM Cdliff Assay performed on the BID MAXTM System is an automated in vitro diagnostic test for the dir… | 2008 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2025 | Class II | Z-0238-2026 | Software design | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may… |
| Oct 31, 2024 | Class II | Z-0590-2025 | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142422 (Roche Molecular Systems, Inc., 2015) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K081920.
How does its category compare?
All OZN devicesOZN C. Difficile Toxin Gene Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OZN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZN
89in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OZN
3in 2025
MAUDE reports naming product code OZN, 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 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 4 | 79 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | 89 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 1 | 7 |
| 2025 | 1 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BD MAX™ Cdiff Assay performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having C. difficile infection (CDI). The test, performed directly on the specimen, utilizes real-time polymerase chain reaction (PCR) for the amplification of C. difficile toxin B gene DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ Cdiff Assay is intended to aid in the diagnosis of CDI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130470: BD Max Cdiff Assay, BD Max Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130470
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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