# K091409: Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jul 6, 2010 after 419 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.
- K042357: Idi-Mrsa Assay, Infectio Diagnostic (I.D.I.), Inc. (2004) Summary page 1.

## Most influential descendants
- K142721: cobas MRSA/SA Test (2014), 0 descendants of its own

## Indications for use
The LightCycler® MRSA Advanced Test is a qualitative in vitro diagnostic test for the direct detection of nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on the LightCycler® 2.0 Instrument with nasal swab specimens from patients suspected of colonization, uses swab extraction and mechanical lysis for specimen preparation followed by polymerase chain reaction (PCR) for the amplification of MRSA DNA, and fluorogenic target specific hybridization probes for the detection of the amplified DNA. The LightCycler® MRSA Advanced Test is not intended to diagnose, guide or monitor treatment for MRSA infections. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K091409
Methodology: https://510kreport.com/methodology