510(k) · Cleared
Recalled · Class II · 2025Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Aug 18, 2016 as substantially equivalent to K131813 (Quidel Corp., 2013) after a 92-day review. Its family tree reaches back 5 generations to 2008. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 18, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- OCC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070013 (2008). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 4 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 3 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 1 generation backK131813 Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
- This deviceK161375 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i…Alere Scarborough, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK190204 ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019
- Descendant · 2 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 · 3 generations on · 0 of its ownK191534 ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. · 2018 · cites it directly3descendants
- K190204ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019 · 2 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 · 2 generations on0descendants
- K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −4 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −3 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −2 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −1 | K131813 | Quidel Molecular RSV + HMPV Assay | Quidel Corp. | 2013 | — |
| 0 (this device) | K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 2016 | — |
| +1 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | — |
| +2 | K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019 | — |
| +2 | 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 | — |
| +3 | K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K131813 | Quidel Molecular RSV + HMPV AssaySummary page 4…ex Test Systems (per 21 CFR 862.2570) CLASSIFICATION Class II PRODUCT CODE OCC, OOI PANEL Microbiology (83) PREDICATE DEVICE Quidel Molecular RSV + hMPV Assay (Lyra) K131813 Alere™ i RSV Page 1 510(k) Notification – Confid… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2025 | Class II | Z-1573-2025 | Process change control | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| Mar 4, 2025 | Class II | Z-1576-2025 | Process change control | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K173932 (Alere Scarborough, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K131813.
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. 2016, 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 Alere™ i RSV assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children <18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161375: Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161375
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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