(134 days)
No
The description focuses on automated sample processing and real-time PCR, with no mention of AI or ML terms or functionalities.
No
This device is for in vitro diagnostic (IVD) use, specifically for performing nucleic acid testing, which means it aids in diagnosis rather than directly treating a disease or condition.
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 description explicitly states it is an "instrument" capable of automated lysis, dilution, amplification, and detection, which are hardware-based functions.
Yes, the provided text explicitly states that the Revogene® instrument is an IVD (In Vitro Diagnostic).
This is mentioned multiple times in both the "Intended Use / Indications for Use" and "Device Description" sections.
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 instrument is a system that performs automated lysis and dilution of samples, followed by automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR. It identifies reagents and patient specimens using two barcode readers, providing traceability. Each process contains an internal process control (PrC) for DNA assays, or an Internal Control (IC) and Microfluidic Control (MFC) for RNA assays, to monitor amplification inhibition, assay reagents, and sample processing effectiveness. It can process and analyze up to 8 specimens per run and has 4 optical channels. The system is factory calibrated. The current submission is a Special 510(k) to upgrade the firmware to add a cooling sequence before lid opening in case of run interruption.
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
Clinical laboratories. For prescription 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The submission refers to previous 510(k)s for analytical and clinical performance studies: K220480 (Revogene Instrument), K170557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), and K190275 (Revogene Carba C). This Special 510(k) is for a firmware modification to add a cooling sequence, which does not affect the device's intended use or fundamental scientific technology.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 26, 2023
Meridian Bioscience, Inc Jack Rogers Regulatory Affairs Principal 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K222779
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: September 14, 2022 Received: September 14, 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 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 -S
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) K222779
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) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY
Applicant Information A.
| Submission Date: | September 14, 2022 |
|---|---|
| Submitter Information: | Meridian Bioscience, Inc. |
| 3471 River Hills Drive | |
| Cincinnati, Ohio 45244 | |
| Contact Person: | Jack Rogers |
| Regulatory Affairs Principal | |
| Meridian Bioscience, Inc | |
| Meridian Bioscience, Inc | |
| Tel: 513.991.2319 | |
| 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 (75) |
D. Purpose of Submission
To upgrade the current Revogene® firmware to add a cooling sequence before lid opening in case of run interruption. 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 (optional) |
F. Device Modification Description
The Revogene was previously cleared under K220480. Meridian Biosciences, Inc. is submitting this Special 510(k) to implement a modification to the Revogene firmware in order to add a cooling sequence before lid opening in case of run interruption. The cooling sequence is added to ensure that users do not have access to hot parts upon run abortion.
Substantial Equivalence Information G.
| Predicate device: | Revogene® |
|---|---|
| Predicate Device Number: | K220480 |
Comparison with Predicate:
| Modified Device | Predicate Device | |
|---|---|---|
| Item | Revogene® | |
| (Subject of Special 510(k)) | Revogene® (K220480) | |
| 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 | |
| Modified Device | Predicate Device | |
| Item | Revogene® | |
| (Subject of Special 510(k)) | Revogene® (K220480) | |
| 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 |
| 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 |
| Item | Modified Device | |
| Revogene® | ||
| (Subject of Special 510(k)) | Predicate Device | |
| Revogene® (K220480) | ||
| 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 |
| Differences | ||
| Firmware | ||
| Cooling | ||
| Sequence | Firmware Configuration Modification for the stop sequence to add a cooling sequence before lid opening in the cases where runs are interrupted by the instrument | No cooling sequence in the cases where runs are interrupted by the instrument |
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Performance Characteristics H.
1. Analytical Performance
See K220480 (Revogene Instrument), K170557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), and K190275 (Revogene Carba C).
2. Clinical Performance
See K220480 (Revogene Instrument), K190275 (Revogene Carba C), K183366 (Revogene Strep A), K172569 (Revogene C. difficile), and K170557 (Revogene GBS LB).
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 modified Revogene instrument is safe, effective, and substantially equivalent to the legally marketed device.