510(k) · Cleared
ClearedImdx C.Difficile for Abbott M2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Medical Devices, Inc. · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Oct 11, 2013 as substantially equivalent to K123355 (Quidel Corporation, 2012) after an 85-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Oct 11, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- OZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123355 (2012). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK123355 Amplivue C. Difficile AssayQuidel Corporation · 2012
- This deviceK132235 Imdx C.Difficile for Abbott M2000Intelligent Medical Devices, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123355 | Amplivue C. Difficile Assay | Quidel Corporation | 2012 | — |
| 0 (this device) | K132235 | Imdx C.Difficile for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K123355 | Amplivue C. Difficile AssaySummary page 2…proceeded correctly for each specimen. Substantial Equivalency IMDx C difficile for Abbott m2000 is substantially equivalent to theQuidel AmpliVueTM C. difficile assay (K123355). Table I compares the characteristics of the IMDx C dif/kcile assay (New Device) and the Quidel Amplivue C. difficile assay(Pred… | 2012 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
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 IMDx C. difficile for Abbott m20C0 assay is an in vitro diagnostic assay that uses real-time polymerase chain reaction.(PCR) amplification for the qualitative detection of nucleic acids encoding the toxin A gene (tcdA) and toxin B gene (tcdB ) sequences of toxigenic strains of Clostridium diffidile in human liquid or soft stool specimens collected from patients suspected of having symptoms of Clostridium difficile infection. The assay is intended to…
Read the full statement (170 words)
The IMDx C. difficile for Abbott m20C0 assay is an in vitro diagnostic assay that uses real-time polymerase chain reaction.(PCR) amplification for the qualitative detection of nucleic acids encoding the toxin A gene (tcdA) and toxin B gene (tcdB ) sequences of toxigenic strains of Clostridium diffidile in human liquid or soft stool specimens collected from patients suspected of having symptoms of Clostridium difficile infection.
The assay is intended to be performed on the Abbott m2000 System (which comprises the Abbott m2000sp and m:2000rt instruments) and is indicated for use as an aid in the diagnosis of Clostridium di~flcile infection. The test is intended to be used directly on liquid or soft stool specimens (unpreserved stool, or stool preserved in Gary Blair transport medium). Negative results do not preclude toxigenic C difficile infection and should not be used as the sole basis for treatment or other patient management decisions. The IMDx C. difficile for Abbott m2600 assay is intended for professional use. The device is not intended for point-of-care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132235 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132235: Imdx C.Difficile for Abbott M2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132235
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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