# K093383: Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 6, 2010 after 249 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: 1 generation back to K082562 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082562: Applied Biosystems 7500 Fast DX, Applied Biosystems, Inc. (2008) Summary page 1.

## Most influential descendants
- K102740: Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt); Nuclisens Director V.2.6 (2011), 0 descendants of its own

## Recalls of this device
- May 10, 2011 · Not classified · Z-2740-2011: The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.

## Indications for use
The NucliSENS EasyQ Analyzer and the accompanying NucliSENS EasyQ Director software are intended for in vitro diagnostic use in conjunction with FDA-cleared or approved NucliSENS assay protocols. The user shall be a properly trained laboratory technician familiar with performing nucleic acid assays. The analyzer is intended to measure fluorescent readings from molecular beacon probes binding to amplified RNA or DNA in samples containing NucliSENS EasyQ assay reagents while controlling the temperature of the samples. The NucliSENS EasyQ Director software is intended to control instrument operations and organize the assays to be performed. In addition, the software is intended to automatically calculate results for each test request based on raw measurement data, the data reduction algorithm specified for the assay, and the batch parameters of the reagents used for the test.

Source page: https://510kreport.com/device/K093383
Methodology: https://510kreport.com/methodology