(143 days)
No
The software modification describes a "PMT surveillance algorithm" that monitors raw data fluorescence signals and identifies issues based on a malfunction. This sounds like a rule-based or threshold-based algorithm, not necessarily AI/ML. There is no mention of learning, training data, or complex pattern recognition typically associated with AI/ML.
No.
The device is an in vitro diagnostic (IVD) instrument used for performing nucleic acid testing in clinical laboratories, which means it is used to diagnose diseases and not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Revogene instrument is "intended for in vitro diagnostic (IVD) use."
No
The device described is a software modification to an existing hardware instrument (Revogene). The software's function is to monitor a hardware component (PMT) and lock the instrument if a malfunction is detected. It is not a standalone software device.
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 was previously cleared under K170558. Meridian Biosciences, Inc. is submitting this 510(k) to implement a software modification to the Revogene that updates the current software with a PMT surveillance algorithm. The software monitors raw data fluorescence signal during assay testing and identifies issues due to a malfunction of the photomultiplier tube (the "PMT"), a key component in the Revogene instrument's optics system used in the management of fluorescence signals. Upon detection of a PMT malfunction, the PMT surveillance algorithm software produces a specific error code to the user labeled "Detection Error" and will lock the instrument thereby preventing further use.
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
in clinical laboratories.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
See K170558 (Revogene Instrument), K170557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), and K190275 (Revogene Carba C).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K170557, K172569, K183366, K190275
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2022
Meridian Bioscience, Inc Jack Rogers Regulatory Affairs Principal 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K220480
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: February 17, 2022 Received: February 18, 2022
Dear Jack Rogers:
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
1
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 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 (OS) 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) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220480
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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510(k) SUMMARY INSTRUMENT ONLY
A. Applicant Information
| Submission Date: | February 17, 2022 |
|---|---|
| Submitter Information: | Meridian Bioscience, Inc. |
| 3471 River Hills Drive | |
| Cincinnati, Ohio 45244 | |
| Contact Person: | Jack Rogers |
| Regulatory Affairs Principal | |
| Meridian Bioscience, Inc | |
| Tel: 513-271-3700 | |
| Email: Jack.Rogers@meridianbioscience.com |
B. Proprietary and Established Names
Revogene®
C. Regulatory Information
| Trade Name: | Revogene® |
|---|---|
| Common name: | Revogene instrument |
| 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 |
| Panel: | Clinical Chemistry |
D. Purpose of Submission
To update the current Revogene® software with a PMT surveillance algorithm that includes an improvement to the Revogene System Software's management of fluorescence results. This change does not affect the device's intended use nor alter the device's fundamental scientific technology.
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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 (use if less than 8 samples processed in a single run) |
F. Device Modification Description
The Revogene was previously cleared under K170558. Meridian Biosciences, Inc. is submitting this 510(k) to implement a software modification to the Revogene that updates the current software with a PMT surveillance algorithm. The software monitors raw data fluorescence signal during assay testing and identifies issues due to a malfunction of the photomultiplier tube (the "PMT"), a key component in the Revogene instrument's optics system used in the management of fluorescence signals. Upon detection of a PMT malfunction, the PMT surveillance algorithm software produces a specific error code to the user labeled "Detection Error" and will lock the instrument thereby preventing further use.
G. Substantial Equivalence Information
| Predicate device: | Revogene® |
|---|---|
| Predicate Device Number: | K170558 |
Comparison with Predicate:
| Modified Device | Predicate Device | |
|---|---|---|
| Item | Revogene® | |
| (Subject of 510(k)) | Revogene® (K170558) | |
| 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, DNA amplification and | |
| DNA detection | Same | |
| Item | Modified Device | |
| Revogene® | ||
| (Subject of 510(k)) | Predicate Device | |
| Revogene® (K170558) | ||
| 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 | |
| Level of Concern | Moderate | 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 ID to the PIE | ||
| ID, SBT 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. | ||
| Sample processing is monitored by a | ||
| Microfluidic Control (MFC). | Same | |
| 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 system 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 re- | ||
| calibration. | Same | |
| Software Change | Update of the current software with a PMT | |
| surveillance algorithm | - |
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H. Performance Characteristics
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2. Clinical Performance
See K170558 (Revogene Instrument), K140557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), K190275 (Revogene Carba C)
I. Conclusion
The submitted information demonstrates that the modified Revogene instrument is safe, effective, and substantially equivalent to the legally marketed device.