Revogene

K220480 · Meridian Bioscience, Inc. · OOI · Jul 11, 2022 · Clinical Chemistry

Device Facts

• Record ID: K220480
• Device Name: Revogene
• Applicant: Meridian Bioscience, Inc.
• Product Code: OOI · Clinical Chemistry
• Decision Date: Jul 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

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.

Device Story

Revogene is an automated real-time PCR instrument for clinical laboratories; performs automated lysis, dilution, amplification, and detection of target nucleic acids. Uses disposable microfluidic cartridges (PIEs) to process up to 8 samples simultaneously. Instrument optics include a photomultiplier tube (PMT) for fluorescence signal management. Software update (v4.3.4) adds a PMT surveillance algorithm to monitor raw fluorescence data for glitches indicative of PMT malfunction. Upon detecting a glitch, the algorithm triggers a 'Detection Error' message and locks the instrument to prevent further use, thereby minimizing potential false-positive results. Healthcare providers use the instrument output for diagnostic decision-making; the software change ensures system integrity and result reliability by identifying hardware failures.

Clinical Evidence

No new clinical data provided. The submission relies on the performance characteristics established in the original clearance (K170558) and subsequent assay-specific clearances (K170557, K172569, K183366, K190275).

Technological Characteristics

Real-time PCR instrument; 4 optical channels; automated lysis/amplification. Uses disposable microfluidic PIE cartridges. Software version 4.3.4 includes a PMT surveillance algorithm. Factory calibrated; annual preventive maintenance. Risk management per ISO 14971:2019.

Indications for Use

Indicated for in vitro diagnostic nucleic acid testing of clinical specimens in clinical laboratories. For prescription use only.

Regulatory Classification

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.

Special Controls

*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.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

• Revogene (K170558)

Reference Devices

• Revogene GBS LB (K170557)
• Revogene C. difficile (K172569)
• Revogene Strep A (K183366)
• Revogene Carba C (K190275)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K220480

B Applicant

Meridian Bioscience, Inc

C Proprietary and Established Names

Revogene

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation For Clinical Multiplex Test Systems | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for 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.

B Type of Test:

Real-time PCR

## III Intended Use/Indications for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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A Intended Use(s):
See Indications for Use below.

B Indication(s) 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.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

IV Device/System Characteristics:

A Device Description:
The Revogene instrument was cleared under K170558 and is used with the following Revogene cleared assays:

- Revogene GBS LB (cleared on May 25, 2017 under the name of GenePOC GBS LB, K170557, software version 3.1.5 and firmware version 0.3.4);
- Revogene C. difficile (cleared on November 22, 2017 under the name of GenePOC CDiff, K172569, software version 3.2.1 and firmware version 0.3.4);
- Revogene Strep A (cleared on March 6, 2019 under the name of GenePOC Strep A, K183366, software version 4.0.10 and firmware version 2.1.0);
- Revogene Carba C (cleared on May 10, 2019 under the name of GenePOC Carba, K190275, software version 4.0.10 and firmware version 2.1.0)

Briefly, the Revogene instrument is similar to a low-speed centrifuge to which are attached the necessary components to perform the different steps of the diagnostic tests. It uses a disposable microfluidic cartridge (named PIE) that contains the reagents required for analyte detection. The Revogene can process from one (1) up to a maximum of eight (8) samples simultaneously in the same run. The instrument must contain eight (8) PIEs. If eight (8) PIEs are not available, empty spaces should be filled with MOCK PIEs.

The Revogene System is composed of the following:

- The Revogene instrument
- Revogene IVD Assays
- MOCK PIEs [A MOCK PIE mimics a test PIE and is used to complete the rotor when less than eight (8) samples are processed in a single run. MOCK PIEs help maintain the thermodynamic balance within a run]

In K220480, the device has been modified to implement a software change to 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's optics system used in the management of fluorescence signals. Upon detection of a PMT malfunction, the PMT

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surveillance algorithm software produces a specific error code to the user labeled “Detection Error” and will lock the instrument thereby preventing further use.

Please refer to K170558 for additional information about the Revogene System.

## B Instrument Description Information:

1. Instrument Name:
Revogene

2. Specimen Identification:
See K170558

3. Specimen Sampling and Handling:
See K170558

4. Calibration:
See K170558

5. Quality Control:
See K170558

## V Substantial Equivalence Information:

### A Predicate Device Name(s):
Revogene

### B Predicate 510(k) Number(s):
K170558

### C Comparison with Predicate(s):

| Device & Predicate Device(s): | K220480
(Subject Device) | K170558
(Predicate Device) |
| --- | --- | --- |
| Device Trade Name | Revogene | Revogene |
| General Device
Characteristic Similarities | | |
| 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 | Same |

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| | 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. | |
| --- | --- | --- |
| Sample Preparation Method | Automated cell lysis, DNA amplification and DNA detection | Same |
| Mode of Operation | Real-time Polymerase chain reaction with fluorogenic detection of amplified DNA | |
| Sample analysis and result determination | Combination of software, instrument control protocols and assay definition files developed and determined by firm | 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 |
| 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 |

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| Instrument Calibration | The system is factory calibrated by the manufacturer, and it 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 |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| Software Change | Update of the current software with a PMT surveillance algorithm | |

VI Standards/Guidance Documents Referenced:

ISO 14971:2019—Medical devices - Applications of risk management to medical devices

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
See K170558 (Revogene Instrument), K170557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), and K190275 (Revogene Carba C).

2. Linearity:
N/A

3. Analytical Specificity/Interference:
See K170558 (Revogene Instrument), K170557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), and K190275 (Revogene Carba C).

4. Accuracy (Instrument):
N/A

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5. Carry-Over:

See K170558 (Revogene Instrument), K170557 (Revogene GBS LB), K172569 (Revogene C. difficile), K183366 (Revogene Strep A), and K190275 (Revogene Carba C).

B Other Supportive Instrument Performance Characteristics Data:

Software Change

The software change is for the addition of a surveillance algorithm to the Revogene System Software capable of detecting glitches associated with the PMT. This algorithm will prevent the processing of raw data presenting glitches by the Results Processor and thus will minimize the reporting of potential false-positive results. Verification and validation activities were performed to ensure outputs met design inputs and that the Revogene System Software (version 4.3.4), as a portion of the Revogene platform, met user needs, the intended use, and software requirements.

PMT Surveillance Algorithm Performance

The PMT surveillance algorithm design was assessed by running the algorithm on a dataset constituting 593 runs, of which 500 runs were identified as normal runs that presented no PMT glitches.

The PMT surveillance algorithm was able to:

- Identify correctly 100% of the normal runs
- Identify the glitches in 83 out of 93 runs with PMT failures (89.2%)
- Identify the glitches in 27 runs out of 29 runs with PMT failures leading to false positive results (93.1%).

The surveillance algorithm was shown to flag instruments containing a faulty PMT and was observed to have no impact on instruments that do not generate glitches. Detection error messages were shown where glitches related to the PMT issue were identified. Testing indicated that software version 4.3.4 could successfully process a multi-assay run, and therefore, has no impact on the compatibility between the various Revogene assays.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.