(212 days)
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No
The description focuses on automated PCR processes and data analysis, but there is no mention of AI or ML algorithms being used for result interpretation or any other function.
No
The device is described as an "in vitro diagnostic test" for detecting the tcdB gene of toxigenic C. difficile, intended for use as an "aid in the diagnosis" of C. difficile infection. It does not directly treat or alleviate a disease, but rather provides information for diagnosis.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an aid in the diagnosis of CDI in humans." Additionally, the "Device Description" mentions that it is an "in vitro diagnostic test."
No
The device description clearly outlines a system that includes hardware components (cobas® Liat® Analyzer, assay tubes, actuators) that perform physical processes (reagent preparation, extraction, amplification, detection). While software controls these processes, it is integral to a larger hardware system, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is an "automated, qualitative in vitro diagnostic test". It also describes its use for detecting a specific target (tcdB gene of toxigenic Clostridioides difficile) in a biological sample (stool) to aid in the diagnosis of a condition (CDI). This aligns perfectly with the definition of an in vitro diagnostic device.
- Device Description: The description repeatedly refers to the system and test as being "for in vitro diagnostic use". It details how the system processes a biological sample to identify the presence of genetic material, which is a core function of many IVDs.
- Predicate Device: The mention of a predicate device (K171770; cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System) further confirms its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OZN, OOI
Device Description
The cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System (cobas® Cdiff) is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of C. difficile DNA in human stool specimens.
The cobas® Liat® is for in vitro diagnostic use. The system is designed to identify and/or measure presence of genetic material in a biological sample. The system automates all nucleic acid amplification test (NAAT) processes, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification, real-time detection, and result interpretation in a rapid manner.
The cobas® Cdiff test detects tcdB target-specific and Internal Control specific oligonucleotide sequences. Toxin B (or tcdB) is a major toxin that is implicated in C. difficile pathogenesis and allows the differentiation between toxigenic and non-toxigenic C. difficile strains. The same Internal Control as in the predicate assay (Bacillus thuringiensis israelensis) is used. Primers and probe oligonucleotide sequences were designed to detect C. difficile genus organisms, as well as with organisms commonly found in normal gut flora. All oligonucleotide sequences remain unchanged from the predicate assay.
The cobas® Cdiff test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. The cobas® Liat® Analyzer automates and integrates sample purification, nucleic acid amplification and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Cdiff assay tube, no reagent preparation or additional steps are required. The cobas® Cdiff assay tube that holds all of the sample purification and PCR reagents and hosts the sample preparation and PCR process specific for the Cdiff analyte. The test uses the assay tube as both the sample and reaction vessel. The assay tube comprises flexible tubing containing all required unit dose reagents pre-packed in tube segments, separated by pressure-sensitive seals, in the order of reagent use.
During the testing process, multiple sample processing actuators of the analyzer compress the cobas® Cdiff assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the test to achieve high performance similar to or better than that of currently available molecular assays. The cobas® Liat® Analyzer software controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Cdiff assay tube, thereby eliminating the potential for cross-contamination between samples. The collected data are automatically analyzed and the result is displayed in the assay report on the integrated LCD touch screen of the cobas® Liat® Analyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the cobas® Cdiff assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Cdiff assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3130 Clostridium difficile toxin gene amplification assay.
(a)
Identification. AClostridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification and detection of target sequences inClostridium difficile toxin genes in fecal specimens from patients suspected of havingClostridium difficile infection (CDI). The detection of clostridial toxin genes, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of CDI caused byClostridium difficile. (b)
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 ofClostridium difficile; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 9, 2021
Roche Molecular Systems, Inc. Gaila Balniene Senior Regulatory Affairs Specialist 4300 Hacienda Drive Pleasanton, California 94588-2722
Re: K210385
Trade/Device Name: cobas Cdiff nucleic acid test for use on the cobas Liat System Regulation Number: 21 CFR 866.3130 Regulation Name: Clostridium Difficile Toxin Gene Amplification Assay Regulatory Class: Class II Product Code: OZN, OOI Dated: February 8, 2021 Received: February 9, 2021
Dear Gaila Balniene:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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cobas® Cdiff Nucleic Acid Test for Use on the cobas® Liat® System 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Roche Molecular Systems, Inc. |
|---|---|
| Address | 4300 Hacienda Drive |
| Pleasanton, CA 94588-2722 | |
| Contact | Gaila Balniene |
| Phone: (510) 305-6980 | |
| FAX: (925) 225-0207 | |
| Email: gaila.balniene@roche.com | |
| Date Prepared | February 9, 2021 |
| Proprietary Name | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System |
| Common Name | Clostridioides difficile Test |
| Classification Name | Clostridioides difficile Toxin Gene Amplification |
| Assay Real Time Nucleic Acid Amplification | |
| System | |
| Product Codes | OZN, OOI |
| Regulation Number | 21 CFR 866.3130 |
| Predicate Devices | cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System |
| Establishment Registration | Roche Molecular Systems, Inc. Branchburg, NJ |
| Establishment Number: 2243471 |
Roche Molecular Systems, Inc. Pleasanton, CA
Establishment Number: 3004141078 |
1. DEVICE DESCRIPTION
The cobas® Cdiff Nucleic Acid Test for use on the cobas® Liat® System (cobas® Cdiff) is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of C. difficile DNA in human stool specimens.
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The cobas® Liat® is for in vitro diagnostic use. The system is designed to identify and/or measure presence of genetic material in a biological sample. The system automates all nucleic acid amplification test (NAAT) processes, including reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, amplification, real-time detection, and result interpretation in a rapid manner.
Target Selection 1.1.
The cobas® Cdiff test detects tcdB target-specific and Internal Control specific oligonucleotide sequences. Toxin B (or tcdB) is a major toxin that is implicated in C. difficile pathogenesis and allows the differentiation between toxigenic and non-toxigenic C. difficile strains. The same Internal Control as in the predicate assay (Bacillus thuringiensis israelensis) is used. Primers and probe oligonucleotide sequences were designed to detect C. difficile genus organisms, as well as with organisms commonly found in normal gut flora. All oligonucleotide sequences remain unchanged from the predicate assay.
Test Principle 1.2.
The cobas® Cdiff test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. The cobas® Liat® Analyzer automates and integrates sample purification, nucleic acid amplification and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Cdiff assay tube, no reagent preparation or additional steps are required. The cobas® Cdiff assay tube that holds all of the sample purification and PCR reagents and hosts the sample preparation and PCR process specific for the Cdiff analyte. The test uses the assay tube as both the sample and reaction vessel. The assay tube comprises flexible tubing containing all required unit dose reagents pre-packed in tube segments, separated by pressure-sensitive seals, in the order of reagent use.
During the testing process, multiple sample processing actuators of the analyzer compress the cobas® Cdiff assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the test to achieve high performance similar to or better than that of currently available molecular assays. The cobas® Liat® Analyzer software controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Cdiff assay tube, thereby eliminating the potential for cross-contamination between
5
samples. The collected data are automatically analyzed and the result is displayed in the assay report on the integrated LCD touch screen of the cobas® Liat® Analyzer.
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.
3. TECHNOLOGICAL CHARACTERISTICS
The primary technological characteristics and intended use of cobas® Cdiff for use on the cobas® Liat® System, when used with cobas®Liat® Analyzer Software 3.3 are substantially equivalent to the legally marketed device, which was most recently cleared with cobas® Liat® Analyzer Software 3.0. Table 1 provides a comparison of the modified device to the predicate device, as cleared through K171770.
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| Item Name | Submitted Device:
cobas® Cdiff w/ cobas® Liat® System Software 3.3 | Predicate Device: K171770
cobas® Cdiff w/ cobas® Liat® System Software 3.0 |
|-------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | 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. |
| Conditions for Use | Same | For prescription use |
| Regulation
Number | Same | 21 CFR 866.3130 |
| Classification | Same | Clostridioides difficile Toxin Gene Amplification Assay
Real Time Nucleic Acid Amplification System |
| Product Code | Same | OZN, OOI |
| Sample Type | Same | Unformed soft stool specimens |
| Amplification
Technology | Same | Real-time PCR |
| Detection
Technique | Same | Multiplex assay using different reporter dyes for each target |
| Error
Diagnostic
System | Same | Yes, monitors and records system parameters for error recover or abort if
unrecoverable |
| Internal Control | Same | A gram-positive Bacillus thuringiensis israelensis bacterial organism to monitor the
full process of cobas® Liat® Analyzer. Native sequence in the bacteria is used as the
Internal Control Target. |
| Positive Control | Same | Plasmid in buffer |
| Negative Control | Same | Buffer only |
| Analyte Targets | Same | Toxin B ( tcdB ) gene |
| Sample Collection
Devices | Same | cobas® PCR Media Swab Sample Kit |
| Item Name | Submitted Device:
cobas® Cdiff w/ cobas® Liat® System Software 3.3 | Predicate Device: K171770
cobas® Cdiff w/ cobas® Liat® System Software 3.0 |
| Sample
Preparation | Same | Magnetic bead-based nucleic acid extraction automated by cobas® Liat® Analyzer |
| Result Analysis | Same | Based on PCR cycle threshold analysis |
| Subject Status | Same | Symptomatic |
| Assay Instrument | Same | cobas® Liat® Analyzer |
| Software | cobas® Liat® Analyzer Core Software 3.3 cobas® Cdiff Assay Script CDFA 1.1 | cobas® Liat® Analyzer Core Software 3.0 cobas® Cdiff Assay Script CDFA 1.0 |
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4. DESCRIPTION OF CHANGE: CORE SOFTWARE
cobas® Liat® Analyzer Software 3.3 incorporates the following changes:
- Operating System Migration to LINUX OS .
- Patient Verification .
- Translations (not applicable to US customers) .
- Enhanced Data Encryption .
- . Thermal Printer Support
- Generic Calculation Engine (not applicable to cleared assays) .
- Assay Masking .
- Integration of Advanced Tools .
- Correction of defects (bug fixes) .
5. DESIGN AND DEVELOPMENT ACTIVITY SUMMARY
Roche Molecular Diagnostics (RMD), Pleasanton, CA designed and developed the core software component of the cobas® Liat® System. The cobas® Liat® Analyzer core software was designed and developed by Roche Molecular Diagnostics in Rotkreuz, Switzerland.
RMD in Pleasanton and Rotkreuz coordinated the development and verification of cobas® Liat® Analyzer Software 3.3 at the Product Requirements, Technical Requirements and Technical Requirement Specifications (Unit Specifications) level. These activities included risk management, requirements management, configuration management, verification testing, and regression analysis.
6. ASSAY PERFORMANCE
Performance of the cobas® Cdiff assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Cdiff assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version.
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CONCLUSION 7.
Equivalent performance of the modified device and the current commercial device has been demonstrated, and analytical or clinical performance has not changed. The modified device is substantially equivalent to the predicate device, as cleared through K171770.