510(k) · Cleared
ClearedLightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Jul 6, 2010 as substantially equivalent to K033415 (Infectio Diagnostic (I.D.I.), Inc., 2004) and 1 other predicate after a 419-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Jul 6, 2010
- Review
- 419 days
- Class
- Class II
- Product code
- NQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850291 (1985). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- 1 generation backK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- This deviceK091409 Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0…Roche Molecular Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK142721 cobas MRSA/SA TestRoche Molecular Systems, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K142721cobas MRSA/SA TestRoche Molecular Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −1 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| 0 (this device) | K091409 | Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument… | Roche Molecular Systems, Inc. | 2010 | — |
| +1 | K142721 | cobas MRSA/SA Test | Roche Molecular Systems, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQX device
- #1 K243625 Xpert MRSA/SA SSTIscore 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033415 | Idi-MrsaSummary page 1…me Classification Advisory: Microbiology Committee: Predicate Device: RID Gene~hMTM MRSA Assay (510(k) numbers K033415/K042357) 51 0(k) Prernarket Application CONFIDENTIAL AND PROPRIETARY 510(k) Summary Print… | 2004 |
| * | K042357 | Idi-Mrsa AssaySummary page 1…ssification Advisory: Microbiology Committee: Predicate Device: RID Gene~hMTM MRSA Assay (510(k) numbers K033415/K042357) 51 0(k) Prernarket Application CONFIDENTIAL AND PROPRIETARY 510(k) Summary Print Date: Ju… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142721 | cobas MRSA/SA Test | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K142721 (Roche Molecular Systems, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033415.
How does its category compare?
All NQX devicesNQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NQX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQX
75in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQX
15in 2025
MAUDE reports naming product code NQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 70 | 1 | 1 |
| 2011 | 2 | — | 6 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 75 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 2 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (121 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091409: Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091409
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026