Revogene

K222779 · Meridian Bioscience, Inc. · OOI · Jan 26, 2023 · Clinical Chemistry

Device Facts

• Record ID: K222779
• Device Name: Revogene
• Applicant: Meridian Bioscience, Inc.
• Product Code: OOI · Clinical Chemistry
• Decision Date: Jan 26, 2023
• Decision: SESE
• Submission Type: Special
• 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, multiplex clinical test system; performs molecular diagnostic assays. Modification involves firmware update to implement cooling sequence prior to lid opening during run interruption. Device operates in clinical laboratory settings; used by trained laboratory personnel. Output provides diagnostic test results to clinicians for patient management. Firmware modification ensures safety during instrument access following interruptions.

Clinical Evidence

No new clinical data provided. Substantial equivalence is supported by the previously cleared predicate device (K220480) and associated analytical/clinical performance data from prior submissions (K170557, K172569, K183366, K190275).

Technological Characteristics

Instrumentation for clinical multiplex test systems. Firmware-controlled automated molecular diagnostic platform. Modification: firmware update for cooling sequence. Fundamental scientific technology unchanged.

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 (K222779)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K222779

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 Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed**. This change was for modifications to upgrade the current Revogene firmware to add a cooling sequence before lid opening in case of run interruption.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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