510(k) · Cleared
ClearedIceplex C. Difficile Assay Kit, Iceplex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primeradx · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Nov 29, 2013 as substantially equivalent to K130470 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2013) after a 91-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Nov 29, 2013
- Review
- 91 days
- Class
- Class II
- Product code
- OZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923463 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 2 generations backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- 1 generation backK130470 BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · Recalled
- This deviceK132726 Iceplex C. Difficile Assay Kit, Iceplex SystemPrimeradx · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −2 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| −1 | K130470 | BD Max Cdiff Assay, BD Max Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013 | 2 |
| 0 (this device) | K132726 | Iceplex C. Difficile Assay Kit, Iceplex System | Primeradx | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K130470 | BD Max Cdiff Assay, BD Max InstrumentSummary page 4….SUBSTANTIAL EQUIVALENCE COMPARISON a. PREDICATE DEVICE NAME BD Max C duff Assay b. PREDICATE DEVICE 510(K) NUMBER K130470 PrimeraDx, Inc. 5 10(k) 510(k) Summary ICEPlex C. difficile Kit on the ICEP… | 2013 |
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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130470.
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 PrimeraDx ICEPlex® C. difficile Assay Is for the qualitative detection of the Clostridium difficile toxin B gene (tcdB gene) in nucleic acids purified from unpreserved liquid or soft human stool specimens from patients suspected of having C. difficile Infection (CDI).
The ICEPlex C.difficile Assay Is intended to be used only on the ICEPlex® System, which integrates PCR-based amplification with capillary electrophoresis (CE) for the detection of amplification products. The assay is intended to aid in the diagnosis of CDI. Results should be considered in conjunction with patient clinical history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132726: Iceplex C. Difficile Assay Kit, Iceplex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132726
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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