← Product Code [OZN](/productcode/OZN) · K260045

# cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) (K260045)

_Roche Molecular Systems, Inc. · OZN · Aug 28, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260045

## Device Facts

- **Applicant:** Roche Molecular Systems, Inc.
- **Product Code:** [OZN](/productcode/OZN.md)
- **Decision Date:** Aug 28, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3130
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/device/K260045](https://fda.innolitics.com/device/K260045)

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