# K102740: Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt); Nuclisens Director V.2.6

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 20, 2011 after 240 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850291 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033415: Idi-Mrsa, Infectio Diagnostic (I.D.I.), Inc. (2004) Summary page 2.
- K093383: Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag, bioMerieux, Inc. (2010) Summary page 2.

## Indications for use
The NucliSENS EasyQ® MRSA assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk for nasal colonization. The NucliSENS EasyQ® MRSA assay is performed on the NucliSENS EasyQ® platform. The test utilizes NASBA TM (nucleic acid sequence-based amplification) coupled with molecular beacons (sequence-specific fluorescent probes) to detect the presence of MRSA DNA. The NucliSENS EasyQ® MRSA assay is used as a screening tool to aid in the prevention and control of MRSA infections in health care institutions. NucliSENS EasyQ® MRSA is not intended to diagnose, guide or monitor treatment for MRSA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K102740
Methodology: https://510kreport.com/methodology