510(k) · Cleared
Recalled · Class II · 2017Alere I Influenza a & B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc D/B/A Binax, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Jun 13, 2014 as substantially equivalent to K111387 (Iquum, Inc., 2011) after a 4-day review. Its family tree reaches back 6 generations to 2008. 11 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 13, 2014
- Review
- 4 days
- Class
- Class II
- Product code
- OCC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN070013 (2008). 9 ancestors in all, the oldest DEN060008 (2006). 11 later devices descend from it, 3 citing it directly.
- Root · 6 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 4 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 3 generations backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- 2 generations backK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- 1 generation backK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- This deviceK141520 Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK151464 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B…Alere Scarborough, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- Descendant · 3 generations on · 6 of its ownK171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A &…Alere Scarborough, Inc. · 2017 · Recalled
- Descendant · cites it directly · 4 of its ownK151690 Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015
- 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 2015 · cites it directly8descendants
- K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. · 2016 · 2 generations on7descendants
- K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 2017 · 3 generations on6descendants
- K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −5 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −4 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −3 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| −2 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| −1 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| 0 (this device) | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | — |
| +1 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2015 | — |
| +2 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i… | Alere Scarborough, Inc. | 2016 | — |
| +3 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2017 | 1 |
| +1 | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015 | — |
| +2 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 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? (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 |
|---|---|---|---|
| * | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerSummary page 1…plex Test Systems (per 21 CFR 862.2570) CLASSIFICATION Class 11 PRODUCT CODE 0CC, OZE, 001 PANEL Microbiology (83) PREDICATE DEVICE IQuum Liat M Influenza A/B Assay, K111387 Page 1lofl11 DEVICE… | 2011 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| Jan 25, 2017 | Class II | Z-1231-2017 | Mixed-up of materials/components | Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs. |
| Jun 26, 2015 | Class II | Z-2095-2015 | Process change control | Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit |
| Apr 22, 2015 | Class II | Z-1677-2015 | Under Investigation by firm | High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K151464 (Alere Scarborough, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K111387.
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 Alere'~' I Influenza A & B assay performed on the AlereTh i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in…
Read the full statement (227 words)
The Alere'~' I Influenza A & B assay performed on the AlereTh i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 20 12-2013 influenza season when influenza A/H-3 and A/MINI pandemnic were the predominant influenza A viruses 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/K141520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141520: Alere I Influenza a & B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141520
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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