(90 days)
No
The description focuses on automated PCR processes and embedded calculation algorithms for signal interpretation, without mentioning AI or ML. The changes described relate to hardware (PMT cooling) and software updates, not AI/ML integration.
No.
The Revogene instrument is intended for in vitro diagnostic (IVD) use to perform nucleic acid testing, which means it aids in diagnosis rather than directly treating a disease or condition.
Yes
The device is intended for "in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories," which directly indicates its role in diagnosing diseases.
No
The device is a PCR instrument that includes hardware components such as automated lysis and dilution systems, a fluorescence-based real-time PCR system, and a photomultiplier tube (PMT) cooling system. While it utilizes software and firmware, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories."
N/A
Intended Use / Indications for Use
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
Product codes
OOI
Device Description
The Revogene is a PCR instrument that automates lysis and dilution of samples, followed by nucleic acid amplification, and detection of target sequences by fluorescence-based real-time PCR. Revogene runs are orchestrated by a combination of software, firmware and instrument control protocol that ensures the adequate combination times and temperatures for sample homogenization and PCR analysis. The Revogene instrument acquires fluorescence signals generated during amplification. The signals are then interpreted by the system using embedded calculation algorithms.
The Revogene requires the use of a 'PIE', i.e., an assay-specific cartridge to which a patient sample is added. The PIE contains the reagents needed to process a sample and to perform a PCR amplification. When the number of assay PIEs to be run is lower than eight, the user fills empty spaces with "MOCK PIE", which are cartridges that simulate the presence of an assay PIE to confer thermal and rotational balance.
The Revogene instrument subject of this Premarket Notification is substantially equivalent to the Revogene instrument cleared under K222779. Meridian is submitting this 510(k) Premarket Notification to implement a photomultiplier tube (PMT) cooling system. This cooling system keeps the PMT environment at a temperature that prevents the appearance of fluorescence glitches, which may stop the Revogene instrument.
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
For prescription use only
For in vitro diagnostic use only
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
Functional testing has been conducted using contrived and negative samples in relevant clinical matrix using the following assays, which are representative of the Revogene assays currently on the US market: Revogene® Strep A, Revogene® Carba C and Revogene® SARS-CoV-2 assays.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing has been conducted using contrived and negative samples in relevant clinical matrix using the following assays, which are representative of the Revogene assays currently on the US market: Revogene® Strep A, Revogene® Carba C and Revogene® SARS-CoV-2 assays. No statistically significant differences were observed between the Revogene instruments with and without PMT cooling system for the Positivity/Negativity rates, the Unresolved and Indeterminate results rates and the mean Ct values.
Testing was also carried out to demonstrate that the cooling system reduced the occurrence and amplitude of glitches. The activation of the PMT cooling system resulted in lower glitch amplitude compared to the amplitude documented on instruments run without cooling. No run triggered the prompting of a PMT error signal.
Finally, Revogene equipped with Windows 10 and with upgraded Revogene System Software operates as expected and yields expected assays results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
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March 20, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Meridian Bioscience, Inc. Whitney Rooker Senior Regulatory Affairs Specialist 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K243922
Trade/Device Name: Revogene Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation For Clinical Multiplex Test Systems Regulatory Class: Class II Product Code: OOI Dated: December 19, 2024 Received: December 20, 2024
Dear Whitney Rooker:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve
1
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics OPEQ: Office of Product Evaluation and Quality CDRH: Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K243922
Device Name Revogene
Indications for Use (Describe)
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Meridian Bioscience. The word "meridian" is in a dark blue sans-serif font, with a curved line underneath. To the right of "meridian" is the word "BIOSCIENCE" in a smaller, sans-serif font, with the trademark symbol next to it.
Revogene®
510(k) Summary Meridian Bioscience
A. Applicant Information
| Date of preparation: | March 12, 2025 |
|---|---|
| Submitter Information: | Meridian Bioscience, Inc. |
| 3471 River Hills Drive | |
| Cincinnati, Ohio 45244 | |
| Contact Person: | Whitney Rooker |
| Senior Regulatory Affairs Specialist | |
| Meridian Bioscience, Inc. | |
| Tel: 513.310.4134 | |
| Email: Whitney.Rooker@meridianbioscience.com |
B. Proprietary and Established Names
Revogene®
C. Regulatory Information
| Trade Name: | Revogene® |
|---|---|
| Common name: | Revogene instrument |
| K number: | K243922 |
| Regulation Number: | 21 CFR 862.2570 |
| Regulation Name: | Instrumentation for clinical multiplex systems |
| Regulatory Classification: | Class II |
| Product Code: | OOI - Real-time nucleic acid amplification system |
| Panel: | Clinical Chemistry (75) |
D. Purpose of Submission
This 510(k) Premarket Notification is meant to obtain FDA clearance for a modified version of the Revogene instrument cleared under K222779. A cooling system to reduce the temperature around the photomultiplier tube (PMT) and associated firmware updates are added to mitigate the risk of PMT glitches and Revogene blocking. In addition, the Operating System was upgraded to Windows 10. The Revogene System Software was upgraded to a
Life discovered. Life diagnosed.
4
version compatible with Windows 10. These changes do not affect the device's intended use nor alter the device's fundamental technological characteristics.
E. Intended Use
| Intended Use: | The Revogene® instrument is intended for in vitro diagnostic
(IVD) use in performing nucleic acid testing of specific IVD
assays in clinical laboratories. Revogene is capable of automated
lysis and dilution of samples originating from various clinical
specimen types. Revogene performs automated amplification and
detection of target nucleic acid sequences by fluorescence-based
real-time PCR. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | See Intended Use statement. |
| Special Conditions for
Use Statement: | For prescription use only
For in vitro diagnostic use only |
| Special Instrument
Requirements: | MOCK PIE (optional) |
F. Device Description
The Revogene is a PCR instrument that automates lysis and dilution of samples, followed by nucleic acid amplification, and detection of target sequences by fluorescence-based real-time PCR. Revogene runs are orchestrated by a combination of software, firmware and instrument control protocol that ensures the adequate combination times and temperatures for sample homogenization and PCR analysis. The Revogene instrument acquires fluorescence signals generated during amplification. The signals are then interpreted by the system using embedded calculation algorithms.
The Revogene requires the use of a 'PIE', i.e., an assay-specific cartridge to which a patient sample is added. The PIE contains the reagents needed to process a sample and to perform a PCR amplification. When the number of assay PIEs to be run is lower than eight, the user fills empty spaces with "MOCK PIE", which are cartridges that simulate the presence of an assay PIE to confer thermal and rotational balance.
The Revogene instrument subject of this Premarket Notification is substantially equivalent to the Revogene instrument cleared under K222779. Meridian is submitting this 510(k) Premarket Notification to implement a photomultiplier tube (PMT) cooling system. This cooling system keeps the PMT environment at a temperature that prevents the appearance of fluorescence glitches, which may stop the Revogene instrument
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G. Substantial Equivalence Information
| Predicate device: | Revogene® |
|---|---|
| Predicate Device Number: | K222779 |
Comparison with Predicate:
| Modified Device | Predicate Device | |
|---|---|---|
| Item | Revogene® | |
| (K243922, subject of 510(k) Premarket | ||
| Notification) | Revogene® (K222779) | |
| Similarities | ||
| Classification | Class II | Same |
| Intended Use | The Revogene® instrument is intended for | |
| in vitro diagnostic (IVD) use in performing | ||
| nucleic acid testing of specific IVD assays | ||
| in clinical laboratories. Revogene is | ||
| capable of automated lysis and dilution of | ||
| samples originating from various clinical | ||
| specimen types. Revogene performs | ||
| automated amplification and detection of | ||
| target nucleic acid sequences by | ||
| fluorescence-based real-time PCR. | Same | |
| Sample Preparation | ||
| Method | Automated cell lysis, DNAamplification | |
| and DNA detection | Same | |
| Mode of Operation | Real-time Polymerase chain reaction with | |
| fluorogenic detection of amplified DNA | Same | |
| Sample analysis and | ||
| result determination | Combination of software, instrument | |
| control protocols and assay definition files | ||
| developed and determined by Meridian | Same | |
| Automatic Assay | Yes-result interpretation | Same |
| Sample identification | The instrument has two barcode readers to | |
| identify reagents and patient specimens. It | ||
| provides traceability of the sample | ||
| identification (ID) to the PIE ID, Sample | ||
| Buffer Tube ID, and assay ID. | Same | |
| Internal Process Control | ||
| DNA assays | Each PIE contains an internal process | |
| control (PrC) that controls for amplification | ||
| inhibition, assay reagents, and sample | ||
| processing effectiveness. | Same | |
| Internal Process Control | ||
| RNA assays | Each PIE contains an Internal Control (IC) | |
| that controls for amplification inhibition, | ||
| and assay reagents effectiveness. | Same | |
| Modified Device | Predicate Device | |
| Item | Revogene® | |
| (K243922, subject of 510(k) Premarket | ||
| Notification) | ||
| Sample processing is monitored by a | ||
| Microfluidic Control (MFC). | Revogene® (K222779) | |
| External Control | Materials available commercially but not | |
| required to run the test | Same | |
| DNA Extraction | Cell lysis | Same |
| Specimens per run | Processes and analyzes up to 8 specimens | |
| per run (8 PIEs) | Same | |
| Assay Cartridge | One sample per PIE | Same |
| Single Use | PIE can be used only once | Same |
| Instrument Optical | ||
| Channels | Contains 4 optical channels | Same |
| Instrument Calibration | The instrument is factory calibrated by the | |
| manufacturer and will undergo performance | ||
| qualification testing on-site during annual | ||
| preventive maintenance. If qualification | ||
| testing results determine significant drift, | ||
| the instrument will be returned to the | ||
| manufacturer for recalibration. | Same | |
| Temperature Control | Heating element/fan assembly and cooling | |
| fan for PCR cycling. | Same | |
| Differences | ||
| Operating System | Windows® 10 IoT Enterprise (Windows |
- OS image based on Windows 10
- Update Revogene System Software to
ensure: - compatibility with Windows 10.
- compatibility with Third Party/Off the
Shelf Software - Update the Off the Shelf Software
managing the Revogene database. - Deactivation of internet explorer to
prevent unintended access to internet. - Addition of a "NoAutoUpdate" key in
Windows registry to prevent automatic
updates from being installed | Windows® Embedded Standard
7 (Windows 7) |
| Item | Modified Device | Predicate Device |
| Temperature Control | Revogene®
(K243922, subject of 510(k) Premarket
Notification) | Revogene® (K222779) |
| | PMT cooling system | No PMT cooling system |
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H. Performance Characteristics
Functional testing has been conducted using contrived and negative samples in relevant clinical matrix using the following assays, which are representative of the Revogene assays currently on the US market: Revogene® Strep A, Revogene® Carba C and Revogene® SARS-CoV-2 assays. No statistically significant differences were observed between the Revogene instruments with and without PMT cooling system for the Positivity/Negativity rates, the Unresolved and Indeterminate results rates and the mean Ct values.
Testing was also carried out to demonstrate that the cooling system reduced the occurrence and amplitude of glitches. The activation of the PMT cooling system resulted in lower glitch amplitude compared to the amplitude documented on instruments run without cooling. No run triggered the prompting of a PMT error signal.
Finally, Revogene equipped with Windows 10 and with upgraded Revogene System Software operates as expected and yields expected assays results.
I. Proposed Labeling
The labeling is sufficient, and it satisfies the requirements of 21 CFR Part 809.
J. Conclusion
The submitted information demonstrates that the Revogene instrument equipped with the PMT cooling system is safe, effective, and substantially equivalent to the legally marketed device.