# K220480: Revogene

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Jul 11, 2022 after 143 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: 1 generation back to K170558 (2017). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170558: revogene, Genepoc, Inc. (2017) Summary page 5.

## Most influential descendants
- K222779: Revogene (2023), 1 descendant of its own
- K243922: Revogene (2025), 0 descendants of its own

## 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/K220480
Methodology: https://510kreport.com/methodology