510(k) · Cleared
Recalled · Class II · 2014Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Jul 13, 2012 as substantially equivalent to K092500 (Prodesse, Inc., 2009) and 2 other predicates after a 154-day review. Its family tree reaches back 4 generations to 2008. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 13, 2012
- Review
- 154 days
- Class
- Class II
- Product code
- OCC
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN070013 (2008). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 2 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- This deviceK120413 Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive…Focus Diagnostics, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK142365 Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive…Focus Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK161220 ARIES® Flu A/B & RSV AssayLuminex Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK152408 Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive…Focus Diagnostics, Inc. · 2015 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackFocus Diagnostics · 2014 · cites it directly1descendant
- K161220ARIES® Flu A/B & RSV AssayLuminex Corporation · 2016 · cites it directly0descendants
- K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackFocus Diagnostics, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −2 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −1 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| 0 (this device) | K120413 | Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack | Focus Diagnostics, Inc. | 2012 | — |
| +1 | K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | Focus Diagnostics | 2014 | — |
| +1 | K161220 | ARIES® Flu A/B & RSV Assay | Luminex Corporation | 2016 | 1 |
| +2 | K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | Focus Diagnostics, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K092500 | Modification to Proflu+ AssaySummary page 1…ssay Product Code 0CC - respiratory virus panel nucleic acid assay system Predicate Devices Prodesse, ProFlu+ Assay (K092500, K081030, K073029) INTENDED USE The Focus Diagnostics Simplexa TmFlu A/B & RSV Direct assay is intended for use on the 3M Integr… | 2009 |
| * | K081030 | Modification to Proflu+ AssaySummary page 1…uct Code 0CC - respiratory virus panel nucleic acid assay system Predicate Devices Prodesse, ProFlu+ Assay (K092500, K081030, K073029) INTENDED USE The Focus Diagnostics Simplexa TmFlu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycl… | 2008 |
| * | K073029 | Proflu+ AssaySummary page 1…0CC - respiratory virus panel nucleic acid assay system Predicate Devices Prodesse, ProFlu+ Assay (K092500, K081030, K073029) INTENDED USE The Focus Diagnostics Simplexa TmFlu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instru… | 2008 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2014 | Class II | Z-1958-2014 | Device Design | Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with… |
| Jan 10, 2014 | Class II | Z-0846-2014 | Pending | Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K142365 (Focus Diagnostics, 2014) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K092500.
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. 2012, 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 Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use…
Read the full statement (271 words)
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 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 the 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.
Focus Diagnostics' Simplexa Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120413: Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120413
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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