# K113319: Rotor-Gene Q MDX

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: Feb 6, 2012 after 88 days
- Product code: OOI (Real Time Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922906 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092705: Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501, Abbott Molecular, Inc. (2010) Summary page 1.

## Recalls of this device
- Jan 28, 2020 · Class II · Z-1476-2020: When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false nega

## Indications for use
The Rotor-Gene Q MDx instrument with Rotor-Gene Q software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection. The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.

Source page: https://510kreport.com/device/K113319
Methodology: https://510kreport.com/methodology