Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3130](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3130) → OZN — C. Difficile Toxin Gene Amplification Assay # OZN · C. Difficile Toxin Gene Amplification Assay _Microbiology · 21 CFR 866.3130 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN ## Overview - **Product Code:** OZN - **Device Name:** C. Difficile Toxin Gene Amplification Assay - **Regulation:** [21 CFR 866.3130](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3130) - **Device Class:** 2 - **Review Panel:** [Microbiology](/submissions/MI) ## Identification A Clostridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification and detection of target sequences in Clostridium difficile toxin genes in fecal specimens from patients suspected of having Clostridium difficile infection (CDI). The detection of clostridial toxin genes, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of CDI caused by Clostridium difficile. ## Classification Rationale Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Toxin Gene Amplification Assays for the Detection of Clostridium difficile; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document. ## Special Controls In combination with the general controls of the FD&C Act, the Portrait Toxigenic C. difficile Assay is subject to the following special controls: 1. The special controls for the Clostridium difficile toxin gene amplification assay are contained in the guidance document: "Class II Special Controls Guidance Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile." *Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Toxin Gene Amplification Assays for the Detection of*Clostridium difficile;* Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document. ## Recent Cleared Devices (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243730](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K243730.md) | Xpert C. difficile/Epi | Cepheid® | Feb 28, 2025 | SESE | | [K232092](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K232092.md) | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | Nov 14, 2023 | SESE | | [K212427](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K212427.md) | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Oct 20, 2021 | SESE | | [K210385](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K210385.md) | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Sep 9, 2021 | SESE | | [K172569](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K172569.md) | GenePOC CDiff | Genepoc, Inc. | Nov 22, 2017 | SESE | | [K171770](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K171770.md) | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Sep 12, 2017 | SESE | | [K171441](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K171441.md) | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | Luminex Corporation | Jul 21, 2017 | SESE | | [K170491](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K170491.md) | Solana C. difficile Assay | Quidel Corporation | May 11, 2017 | SESE | | [K163085](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K163085.md) | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | Feb 14, 2017 | SESE | | [K142422](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K142422.md) | cobas Cdiff Test | Roche Molecular Systems, Inc. | May 20, 2015 | SESE | | [K133936](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K133936.md) | ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN GmbH | Apr 4, 2014 | SESE | | [K132726](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K132726.md) | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | Primeradx | Nov 29, 2013 | SESE | | [K132235](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K132235.md) | IMDX C.DIFFICILE FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | Oct 11, 2013 | SESE | | [K130470](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K130470.md) | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | Apr 2, 2013 | SESE | | [K123998](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K123998.md) | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Quidel Corp. | Mar 8, 2013 | SESE | | [K123355](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K123355.md) | AMPLIVUE C. DIFFICILE ASSAY | Quidel Corporation | Dec 13, 2012 | SESE | | [K123197](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K123197.md) | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | Nanosphere, Inc. | Dec 5, 2012 | SESE | ## Top Applicants - Roche Molecular Systems, Inc. — 4 clearances - Quidel Corporation — 2 clearances - Cepheid® — 1 clearance - Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC — 1 clearance - Geneohm Sciences Canada, Inc. (Bd Diagnostics) — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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