510(k) · Cleared
ClearedID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diagnostics Scarborough, Inc. · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Cleared on Jun 24, 2022 as substantially equivalent to K171792 (Alere Scarborough, Inc., 2017) and 1 other predicate after a 98-day review. Its family tree reaches back 10 generations to 2008. 2 later devices descend from it.
- Decided
- Jun 24, 2022
- Review
- 98 days
- Class
- Class II
- Product code
- OZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to DEN070013 (2008). 16 ancestors in all, the oldest DEN060008 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 6 generations between
- 3 generations backK151464 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B…Alere Scarborough, Inc. · 2015
- 2 generations backK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- 1 generation backK171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A &…Alere Scarborough, Inc. · 2017 · Recalled
- This deviceK220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK232775 ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 2023 · Recalled
- Descendant · cites it directly · 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
Show all 10 generations
- Root · 10 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 9 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 8 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 7 generations backK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- 6 generations backK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
- 5 generations backK111387 Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 2011 · Recalled
- 4 generations backK141520 Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 2014 · Recalled
- 3 generations backK151464 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B…Alere Scarborough, Inc. · 2015
- 2 generations backK163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit…Alere Scarborough, Inc. · 2016
- 1 generation backK171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A &…Alere Scarborough, Inc. · 2017 · Recalled
- This deviceK220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −9 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −8 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −7 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| −6 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
| −5 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 4 |
| −4 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 3 |
| −3 | 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 | — |
| −1 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control… | Alere Scarborough, Inc. | 2017 | 1 |
| 0 (this device) | K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | Abbott Diagnostics Scarborough, Inc. | 2022 | — |
| +1 | K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023 | 2 |
| +1 | 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 | — |
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 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitSummary page 5…ex Test Systems (per 21 CFR 862.2570) CLASSIFICATION Class II PRODUCT CODE OCC, OZE, OOI PGX, OOI PANEL Microbiology (83) PREDICATE DEVICE ID NOW™ Influenza A & B 2, K171792 ID NOW™ Strep A 2, K173653… | 2017 |
| * | K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitSummary page 5…862.2570) CLASSIFICATION Class II PRODUCT CODE OCC, OZE, OOI PGX, OOI PANEL Microbiology (83) PREDICATE DEVICE ID NOW™ Influenza A & B 2, K171792 ID NOW™ Strep A 2, K173653 510(K) SUMMARY D… | 2018 |
What descends from it? (2)
2 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 14 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K232775 (Abbott Diagnostics Scarborough, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K171792.
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. 2022, 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 (301 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.
Performance characteristics for influenza A were established during the 2016-2017 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.
ID NOW™ Strep A 2 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220801
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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