510(k) · Cleared
ClearedXpert Flu/RSV XC Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Nov 22, 2014 as substantially equivalent to K110968 (Gen-Probe Prodesse, Inc., 2011) and 3 other predicates after a 117-day review. Its family tree reaches back 7 generations to 2008. 5 later devices descend from it.
- Decided
- Nov 22, 2014
- Review
- 117 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to DEN070013 (2008). 17 ancestors in all, the oldest K910526 (1991). 5 later devices descend from it, 3 citing it directly.
- Root · 7 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 6 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 5 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 4 generations backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- 3 generations backK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- 2 generations backK120911 Xpert Flu Genexpert DX Systems (GX-I, GX-IV)Cepheid · 2012
- 1 generation backK123191 Xpert FluCepheid · 2012
- This deviceK142045 Xpert Flu/RSV XC AssayCepheid · 2014
- Descendant · cites it directly · 4 of its ownK151226 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2015
- Descendant · cites it directly · 2 of its ownK162456 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2017
- Descendant · 2 generations on · 1 of its ownK171552 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert…Cepheid · 2017
- Descendant · 2 generations on · 0 of its ownK180218 Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2018
- Descendant · cites it directly · 0 of its ownK162331 Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2017
Most influential descendants
Showing 5 of 5 · See all- K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid · 2015 · cites it directly4descendants
- K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid · 2017 · cites it directly2descendants
- K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid · 2017 · 2 generations on1descendant
- K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid · 2018 · 2 generations on0descendants
- K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −6 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −5 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −4 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| −3 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| −2 | K120911 | Xpert Flu Genexpert DX Systems (GX-I, GX-IV) | Cepheid | 2012 | — |
| −1 | K123191 | Xpert Flu | Cepheid | 2012 | — |
| 0 (this device) | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | — |
| +1 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert… | Cepheid | 2015 | — |
| +1 | K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx… | Cepheid | 2017 | — |
| +2 | K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal… | Cepheid | 2017 | — |
| +2 | K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal… | Cepheid | 2018 | — |
| +1 | K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx… | Cepheid | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 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 OCC? 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 OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K110968 | Proflu+ AssaySummary page 7…ert Flu Assay and Xpert Flu/RSV XC Assays. Substantial Equivalence: The Xpert Flu/RSV XC Assay is substantially equivalent to the ProFlu+ Assay [510(k) # K110968 and #K132139] and to the current Cepheid Xpert Flu Assay (510(k) #K123191). The ProFlu+ Assay and the Xpert Flu/RSV XC Assay dete… | 2011 |
| * | K132129 | Prodesse Proflu+ AssaySummary page 4…swab specimens: Hologic Prodesse® ProFlu™+ Assay (ProFlu+ Assay) [510(k) #K1109668 and Special 510(k) #K132129]; and, 2) For the detection and differentiation of influenza A and i… | 2013 |
| * | K123191 | Xpert FluSummary page 4…nfluenza B viral RNA in nasal aspirate/wash and nasopharyngeal swab specimens: Cepheid Xpert Flu [510(k) #K123191]. Predicate Devices Copan Universal Transport Medium (UTM-RT) System Ancillary Sample [510(k) #K04297… | 2012 |
| * | K042970 | Copan Universal Transport Medium (Utm-RT) SystemSummary page 4…Cepheid Xpert Flu [510(k) #K123191]. Predicate Devices Copan Universal Transport Medium (UTM-RT) System Ancillary Sample [510(k) #K042970] Collection Kit: Device Description: The Xpert Flu/RSV XC Assay is a rapid, automated in vitro diagnostic t… | 2004 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress… | 2015 | 4 |
| K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems… | 2017 | 2 |
| K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems… | 2017 | 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 6 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K151226 (Cepheid, 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K110968.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, 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 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
The Cepheid Xpert Flu/RSV XC Assay is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu/RSV XC Assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. The Xpert…
Read the full statement (209 words)
The Cepheid Xpert Flu/RSV XC Assay is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu/RSV XC Assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu/RSV XC Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors.
Negative results do not preclude influenza virus or respiratory syncytial 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 2013-2014 influenza season. When other novel 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/K142045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142045: Xpert Flu/RSV XC Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142045
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