(134 days)
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.
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.
The provided document is an FDA 510(k) Substantial Equivalence Determination Decision Summary for the Revogene instrument.
Crucially, this submission (K222779) is a "Special 510(k)" for a firmware modification only, specifically to add a cooling sequence before lid opening in the event of a run interruption.
Therefore, the document does not contain information about a study to prove the device's diagnostic performance against acceptance criteria in the typical sense of analytical or clinical performance (e.g., sensitivity, specificity for detecting a disease). Instead, the performance demonstrated here relates to the safety feature implemented by the firmware update.
Based on the provided text, here's an analysis of the acceptance criteria and study that address the firmware modification:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines the acceptance criteria for this specific modification: the firmware update must successfully implement a cooling sequence before lid opening when a run is interrupted, to prevent access to hot parts.
| Acceptance Criteria (for Firmware Modification) | Reported Device Performance (Implied from the document) |
|---|---|
| The Revogene instrument, with the new firmware, must initiate a cooling sequence prior to lid opening in cases where a run is interrupted. | The firmware configuration was modified to add a cooling sequence before lid opening in cases where runs are interrupted by the instrument. This change ensures users do not have access to hot parts upon run abortion. |
| The cooling sequence must effectively prevent users from accessing hot parts upon run abortion. | (Implied to be successful, as the FDA has cleared the device based on this change, and the purpose is explicitly stated as ensuring safety from hot parts.) |
| The modification must not affect the device's intended use (IVD nucleic acid testing). | "This change does not affect the device's intended use nor alter the device's fundamental scientific technology." |
| The modification must not alter the device's fundamental scientific technology. | "This change does not affect the device's intended use nor alter the device's fundamental scientific technology." |
2. Sample size used for the test set and the data provenance:
The document does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for testing this firmware modification. This is expected given the nature of a Special 510(k) for a safety-related firmware update. The FDA's decision to clear the device implies they were satisfied with the internal validation conducted by the manufacturer to demonstrate the successful implementation of this safety feature. No clinical data or large-scale analytical testing is typically required for such minor safety updates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of firmware modification. The ground truth here is a functional safety requirement (i.e., "are hot parts accessible when a run is aborted after the update?"). This would be verified through engineering testing and safety assessments, not typically by expert consensus of clinical or radiological images.
4. Adjudication method for the test set:
Not applicable. This is not a study assessing diagnostic performance where adjudication of ambiguous results would be necessary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an instrument for molecular diagnostics (nucleic acid testing), not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not directly applicable in the typical sense (e.g., for an AI algorithm). The device itself operates "standalone" in its function of automated lysis, amplification, and detection, but the "performance" discussed here is a safety feature of its firmware, not its diagnostic accuracy.
7. The type of ground truth used:
The ground truth for this specific firmware modification is a functional safety performance objective. The "truth" is whether the cooling sequence activates as intended upon run interruption and whether it effectively prevents access to hot parts, thereby improving user safety. This would be established through engineering functional testing and safety verification protocols.
8. The sample size for the training set:
Not applicable. This is a firmware modification for a safety feature, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for a machine learning model is involved.
Summary of the document's relevance to your request:
The provided document is an FDA clearance letter for a firmware upgrade to an existing medical device, the Revogene instrument. This is a very specific type of submission (Special 510(k)) that focuses on demonstrating that a minor change does not adversely affect the device's safety or effectiveness, or alter its fundamental scientific technology.
Therefore, the typical metrics and study designs used for evaluating the diagnostic performance of new AI/ML-based devices (e.g., sensitivity, specificity, MRMC studies, ground truth established by expert consensus or pathology) are not present or applicable here. The "acceptance criteria" and "study" are focused solely on verifying the successful and safe implementation of the firmware's added cooling sequence upon run interruption.
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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
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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 DriveCincinnati, Ohio 45244 |
| Contact Person: | Jack RogersRegulatory Affairs PrincipalMeridian Bioscience, IncMeridian Bioscience, IncTel: 513.991.2319Email: 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 IVDassays in clinical laboratories. Revogene is capable of automatedlysis and dilution of samples originating from various clinicalspecimen types. Revogene performs automated amplification anddetection of target nucleic acid sequences by fluorescence-basedreal-time PCR. |
|---|---|
| Indications for Use: | See Intended Use statement. |
| Special Conditions forUse Statement: | For prescription use onlyFor in vitro diagnostic use only |
| Special InstrumentRequirements: | 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 intendedfor in vitro diagnostic (IVD) use inperforming nucleic acid testing ofspecific IVD assays in clinicallaboratories. Revogene is capable ofautomated lysis and dilution of samplesoriginating from various clinicalspecimen types. Revogene performsautomated amplification and detection oftarget nucleic acid sequences byfluorescence-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 DeviceRevogene®(Subject of Special 510(k)) | Predicate DeviceRevogene® (K220480) |
| InstrumentCalibration | 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 | ||
| FirmwareCoolingSequence | 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.
§ 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.