# K170558: revogene

- Pathway: 510(k) (Traditional)
- Applicant: Genepoc, Inc.
- Decided: May 25, 2017 after 90 days
- Product code: OOI (Real Time Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K220480: Revogene (2022), 2 descendants of its own
- K222779: Revogene (2023), 1 descendant of its own
- K243922: Revogene (2025), 0 descendants of its own

## Recalls of this device
- Jun 22, 2022 · Class II · Z-1479-2022: When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument component
- Feb 15, 2022 · Class II · Z-0836-2022: The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.

## 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. The 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/K170558
Methodology: https://510kreport.com/methodology