510(k) · Cleared
ClearedAlere i Instrument, Alere i Influenza A & B, Alere i Strep A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · OOI Real Time Nucleic Acid Amplification System
Cleared on Jul 16, 2015 as substantially equivalent to K141520 (Alere Scarborough, Inc D/B/A Binax, Inc., 2014) and 1 other predicate after a 23-day review. Its family tree reaches back 7 generations to 2008. 4 later devices descend from it.
- Decided
- Jul 16, 2015
- Review
- 23 days
- Class
- Class II
- Product code
- OOI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to DEN070013 (2008). 12 ancestors in all, the oldest DEN060008 (2006). 4 later devices descend from it, 1 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 backK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- 1 generation backK141520 Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · Recalled
- This deviceK151690 Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015
- 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 |
|---|---|---|---|---|---|
| −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 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| −1 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 3 |
| 0 (this device) | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015 | — |
| +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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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 OOI? 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 OOI device
- #1 K243922 Revogenescore 9.6 · 3 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 |
|---|---|---|---|
| * | K141520 | Alere I Influenza a & BSummary page 5…plification System (per 21 CFR 866.2680) CLASSIFICATION Class II PRODUCT CODES OOI, OCC, OZE, PGX PANEL Microbiology (83) PREDICATE DEVICES Alere™ i Influenza A & B, K141520 Alere ™ i Strep A, K141757 Alere™ i Influenza A & B… | 2014 |
| * | K141757 | Alere I Strep aSummary page 5…CFR 866.2680) CLASSIFICATION Class II PRODUCT CODES OOI, OCC, OZE, PGX PANEL Microbiology (83) PREDICATE DEVICES Alere™ i Influenza A & B, K141520 Alere ™ i Strep A, K141757 Alere™ i Influenza A & B Page 1 Alere™ i Strep… | 2015 |
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)
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 7 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 5 of the 12 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 K141520.
How does its category compare?
All OOI devicesOOI Real Time Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OOI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OOI
249in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OOI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOI
524in 2025
MAUDE reports naming product code OOI, 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 | 249 | 1 | 0 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 134 |
| 2021 | 0 | — | 4 | 324 |
| 2022 | 1 | — | 4 | 874 |
| 2023 | 1 | — | 1 | 220 |
| 2024 | 0 | — | 1 | 327 |
| 2025 | 1 | — | 0 | 524 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Alere™ i Influenza A & B: The Alere™ i Influenza A & B 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 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…
Read the full statement (328 words)
Alere™ i Influenza A & B:
The Alere™ i Influenza A & B 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 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 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic 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.
Alere™ i Strep A:
Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151690: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151690
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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