510(k) · Cleared
ClearedImdx Flu a/B and RSV for Abbott M2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Medical Devices, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Aug 21, 2013 as substantially equivalent to K103209 (Nanosphere, Inc., 2011) after an 82-day review. Its family tree reaches back 6 generations to 2008.
- Decided
- Aug 21, 2013
- Review
- 82 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN070013 (2008). 13 ancestors in all, the oldest DEN060008 (2006). No later device cites it as a predicate yet.
- 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 backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 2 generations backK101855 Profast+ AssayGen-Probe Prodesse, Inc. · 2010
- 1 generation backK103209 Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 2011 · Recalled
- This deviceK131584 Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc. · 2013
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 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −2 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | — |
| −1 | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) | Nanosphere, Inc. | 2011 | 1 |
| 0 (this device) | K131584 | Imdx Flu a/B and RSV for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Summary page 2…cy The IMDx Flu A/B and RSV for Abbott in2000 assay is substantially equivalent to the Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene®)System (RV±) (K103209). The tables below compare the characteristics of the IMDx Flu A/B and RSV for Abbott m2000 Assay (New Device) and the Nanosphere… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 3 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K103209.
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. 2013, 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 IMDx Flu A/B and RSV for Abbott m2000 assay performed on the Abbott m2000 System is a qualitative in vitro diagnostic test designed for the detection of influenza A, influenza B, and RSV RNA directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay' detects RNA from influenza A, influenza B, and RSV (A and B3) using real-time, reverse transcription polymerase chain reaction (rRT-PCR) and fluorogenic…
Read the full statement (293 words)
The IMDx Flu A/B and RSV for Abbott m2000 assay performed on the Abbott m2000 System is a qualitative in vitro diagnostic test designed for the detection of influenza A, influenza B, and RSV RNA directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay' detects RNA from influenza A, influenza B, and RSV (A and B3) using real-time, reverse transcription polymerase chain reaction (rRT-PCR) and fluorogenic target specific hybridization for unique sequences in the viral target genomes. The IMDx Flu A/B and RSV for Abbott m2000 assay is intended for use as an aid in diagnosing influenza A and/or influenza B and/or RSV infection.
Negative results for influenza A, influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered when diagnosing respiratory viral infection.
Performance characteristics for influenza A were established during the 2011-2012 and 20 12-2013 influenza seasons when Influenza A/2009 HIMN and Influenza A/H3 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131584: Imdx Flu a/B and RSV for Abbott M2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131584
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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