cobas Cdiff nucleic acid test for use on the cobas Liat System

K212427 · Roche Molecular Systems, Inc. · OZN · Oct 20, 2021 · Microbiology

Device Facts

• Record ID: K212427
• Device Name: cobas Cdiff nucleic acid test for use on the cobas Liat System
• Applicant: Roche Molecular Systems, Inc.
• Product Code: OZN · Microbiology
• Decision Date: Oct 20, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3130
• Device Class: Class 2

Indications for Use

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test, that uses real-time polymerase chain reaction (PCR), for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C.difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile Infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

Device Story

The cobas Cdiff is a rapid, automated in vitro diagnostic test for qualitative detection of C. difficile DNA in human stool. The system uses a closed, self-contained assay tube containing pre-packed reagents. The user adds the stool sample to the tube and inserts it into the cobas Liat Analyzer. The analyzer uses multiple actuators to compress the tube, automating nucleic acid extraction, target enrichment, inhibitor removal, and real-time PCR amplification. The system monitors system parameters for error recovery. Results are displayed on the integrated LCD touch screen. The device is used in clinical settings to aid in the diagnosis of CDI, allowing healthcare providers to make informed clinical decisions based on the presence of the tcdB gene.

Clinical Evidence

No new clinical data provided. The submission relies on design control activities and verification testing to support the shelf-life extension modification.

Technological Characteristics

Real-time PCR assay using silica magnetic particle-based nucleic acid extraction. Employs TaqMan probe-based detection. Closed, self-contained assay tube with pre-packed unit dose reagents. Automated by cobas Liat Analyzer. Internal control: Bacillus thuringiensis israelensis. Software: cobas Liat Analyzer Core Software 3.3 and CDFA 1.1.

Indications for Use

Indicated for the detection of Clostridioides difficile toxin gene amplification in clinical specimens.

Regulatory Classification

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.

Predicate Devices

• cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System (K171770)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K212427

B Applicant

Roche Molecular Systems, Inc.

C Proprietary and Established Names

cobas Cdiff Nucleic acid test for use on the cobas Liat System

D Regulatory Information

1. Regulation section:
21 CFR 866.3130, *Clostridioides difficile* toxin gene amplification assay

2. Classification:
II

3. Product code:
OZN, OOI

4. Panel:
Microbiology (83)

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II devices requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for shelf-life updates only.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for the modified subject devices have been reviewed to verify that the indication/intended use for the devices are unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the devices be determined substantially equivalent to the previously cleared devices.

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