# K243922: Revogene

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Mar 20, 2025 after 90 days
- Product code: OOI (Real Time Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K170558 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222779: Revogene, Meridian Bioscience, Inc. (2023) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K243922
Methodology: https://510kreport.com/methodology