510(k) · Cleared
ClearedQuidel Molecular RSV + HMPV Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Sep 6, 2013 as substantially equivalent to K092500 (Prodesse, Inc., 2009) and 1 other predicate after a 78-day review. Its family tree reaches back 4 generations to 2008. 7 later devices descend from it.
- Decided
- Sep 6, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN070013 (2008). 7 ancestors in all. 7 later devices descend from it, 3 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 backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- This deviceK131813 Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
- Descendant · cites it directly · 4 of its ownK161375 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i…Alere Scarborough, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK190204 ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW…Abbott Diagnostics Scarborough, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK230349 Lyra RSV+hMPV AssayQuidel Corporation · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. · 2016 · cites it directly4descendants
- K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. · 2018 · 2 generations on3descendants
- K190204ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019 · 3 generations on1descendant
- K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc. · 2026 · 3 generations on0descendants
- K230349Lyra RSV+hMPV AssayQuidel Corporation · 2023 · cites it directly0descendants
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 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| 0 (this device) | K131813 | Quidel Molecular RSV + HMPV Assay | Quidel Corp. | 2013 | — |
| +1 | K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 2016 | 2 |
| +2 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | — |
| +3 | K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019 | — |
| +3 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026 | — |
| +1 | K230349 | Lyra RSV+hMPV Assay | Quidel Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K092500 | Modification to Proflu+ AssaySummary page 3…Device Quidel Molecular Prodesse ProFIul Prodesse Pro hMPV+ RSV + hMPV Assay (K092500) (K082688) Intended Use The Quidel The ProPluTM+ Assay The Pro [IMPV+… | 2009 |
| * | K082688 | Pro HMPV+ AssaySummary page 3…Quidel Molecular Prodesse ProFIul Prodesse Pro hMPV+ RSV + hMPV Assay (K092500) (K082688) Intended Use The Quidel The ProPluTM+ Assay The Pro [IMPV+ Molecul… | 2008 |
| † | K122189 | Quidel Molecular RSV + HMPV Assay | 2013 |
What descends from it? (7)
3 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)
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 5 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K161375 (Alere Scarborough, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K092500.
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. 2013, 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 Quidel Molecular RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans…
Read the full statement (202 words)
The Quidel Molecular RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.
Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sale basis for diagnosis, treatment or other patient management decisions.
Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.
The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStuiom Dx RT-PCR Instrument, the Applied Biosystems® 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler® 11 System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131813: Quidel Molecular RSV + HMPV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131813
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