510(k) · Cleared
ClearedID NOW Influenza A & B 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Cleared on Mar 18, 2019 as substantially equivalent to K173932 (Alere Scarborough, Inc., 2018) after a 42-day review. Its family tree reaches back 11 generations to 2008. 1 later device descends from it.
- Decided
- Mar 18, 2019
- Review
- 42 days
- Class
- Class II
- Product code
- OZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to DEN070013 (2008). 22 ancestors in all, the oldest DEN060008 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 7 generations between
- 3 generations backK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- 2 generations backK171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A &…Alere Scarborough, Inc. · 2017 · Recalled
- 1 generation backK173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i…Alere Scarborough, Inc. · 2018
- This deviceK190204 ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191534 ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2019
Show all 11 generations
- Root · 11 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 10 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 9 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 8 generations backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- 7 generations backK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- 6 generations backK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- 5 generations backK141520 Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · Recalled
- 4 generations backK151464 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B…Alere Scarborough, Inc. · 2015
- 3 generations backK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- 2 generations backK171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A &…Alere Scarborough, Inc. · 2017 · Recalled
- 1 generation backK173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i…Alere Scarborough, Inc. · 2018
- This deviceK190204 ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −10 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −9 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −8 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| −7 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| −6 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| −5 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 3 |
| −4 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2015 | — |
| −3 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i… | Alere Scarborough, Inc. | 2016 | — |
| −2 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2017 | 1 |
| −1 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | — |
| 0 (this device) | K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019 | — |
| +1 | 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 | 4 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 OZE? 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 OZE device
- #1 K243274 CDC Human Influenza Virus Real-Time RT-PCR…score 16.0 · 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 |
|---|---|---|---|
| * | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Summary page 4…Multiplex Test Systems (per 21 CFR 862.2570) CLASSIFICATION Class II PRODUCT CODE OCC, OZE, OOI PANEL Microbiology (83) PREDICATE DEVICE Alere™ i Influenza A & B 2, K173932 DEVICE DESCRIPTION ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative det… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191534 | ID NOW Influenza A & B 2 | 2019 | 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 11 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 7 of the 22 ancestors have a recall of any class.
- Of its descendants, K191534 (Abbott Diagnostics Scarborough, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173932.
How does its category compare?
All OZE devicesOZE Influenza A And Influenza B Multiplex Nucleic Acid Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OZE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZE
43in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZE
No recall names OZE since 2007.
Adverse event reports per year · OZE
2in 2025
MAUDE reports naming product code OZE, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 22 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 43 | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ID NOW Influenza A & B 2 assay performed on the ID NOW 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 direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an…
Read the full statement (203 words)
The ID NOW Influenza A & B 2 assay performed on the ID NOW 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 direct nasal or nasopharyngeal swabs and nasal or 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 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.
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/K190204 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190204: ID NOW Influenza A & B 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190204
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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