510(k) · Cleared
Recalled · 2011Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Cleared on Apr 21, 2011 as substantially equivalent to K073029 (Prodesse, Inc., 2008) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 2008. 27 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- OQW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN070013 (2008). 7 ancestors in all, the oldest DEN060008 (2006). 27 later devices descend from it, 2 citing it directly.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 2 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- This deviceK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011
- Descendant · cites it directly · 18 of its ownK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 11 of its ownK141520 Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 8 of its ownK151464 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B…Alere Scarborough, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK120911 Xpert Flu Genexpert DX Systems (GX-I, GX-IV)Cepheid · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · cites it directly18descendants
- K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · 2 generations on11descendants
- K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 2015 · 3 generations on8descendants
- K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. · 2016 · 4 generations on7descendants
- K120911Xpert Flu Genexpert DX Systems (GX-I, GX-IV)Cepheid · 2012 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −2 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −1 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| 0 (this device) | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | — |
| +1 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| +2 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 3 |
| +3 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2015 | — |
| +4 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i… | Alere Scarborough, Inc. | 2016 | — |
| +1 | K120911 | Xpert Flu Genexpert DX Systems (GX-I, GX-IV) | Cepheid | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 OQW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K073029 | Proflu+ AssaySummary page 1…lassification name: Product code: OQW, 0CC, 001 Classification Microbiology (83) Advisory Panel Predicate Devices: K073029: ProFLU+TM Assay, Gen-Probe Prodesse, Inc. K1 00148: SimplexaTM… | 2008 |
| * | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500Summary page 1…Advisory Panel Predicate Devices: K073029: ProFLU+TM Assay, Gen-Probe Prodesse, Inc. K1 00148: SimplexaTM Influenza A H IN] (2009), Focus Diagnostics, Inc. Device Description: The Xpert Flu… | 2010 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2011 | Not classified | Z-2401-2011 | Software design | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K111387 (Iquum, Inc., 2011) has gone furthest, with 18 descendants of its own.
- 9 other devices also cite its predicate K073029.
How does its category compare?
All OQW devicesOQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OQW
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OQW
39in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQW
No recall names OQW since 2007.
Adverse event reports per year · OQW
1in 2011
MAUDE reports naming product code OQW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 22 | 0 | 0 |
| 2011 | 3 | 83 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 39 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cepheid@ Xpert Flu Assay is an automated, multiplex real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B and 2009 H IN I influenza viral RNA. The Xpert Flu Assay uses nasal aspirates/washes and nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The Xpert Flu Assay is…
Read the full statement (204 words)
The Cepheid@ Xpert Flu Assay is an automated, multiplex real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B and 2009 H IN I influenza viral RNA. The Xpert Flu Assay uses nasal aspirates/washes and nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The Xpert Flu Assay is intended as an aid in the diagnosis of influenza. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 HIMi influenza was the predominant influenza A virus in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103766
Report an extraction error
Are you the manufacturer?
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