510(k) · Cleared
ClearedePlex Respiratory Pathogen Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genmark Diagnostics, Incorporated · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Jun 9, 2017 as substantially equivalent to K160068 (Biofire Diagnostics, LLC, 2016) after a 169-day review. Its family tree reaches back 8 generations to 2008.
- Decided
- Jun 9, 2017
- Review
- 169 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN070013 (2008). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 7 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 6 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 5 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 4 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 3 generations backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- 2 generations backK143080 FilmArray Respiratory Panel (RP) for use with Multi-instrument…Biofire Diagnostics, LLC · 2015
- 1 generation backK160068 FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- This deviceK163636 ePlex Respiratory Pathogen PanelGenmark Diagnostics, Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −7 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −6 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −5 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −4 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −3 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| −2 | K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Biofire Diagnostics, LLC | 2015 | — |
| −1 | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 1 |
| 0 (this device) | K163636 | ePlex Respiratory Pathogen Panel | Genmark Diagnostics, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray TorchSummary page 5…ss II Product Code(s): OCC, OEM, OOU, OEP, OTG, OQW, OZE, OZY, OZX, NSU Predicate Device Predicate: FilmArray Respiratory Panel; BioFire Diagnostics; K160068 Page 1 Device Des… | 2016 |
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 9 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K160068.
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. 2017, 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 ePlex® Respiratory Pathogen (RP) Panel is a multiplexed nucleic acid in vitro diagnostic test intended for use on the ePlex® Instrument for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals exhibiting signs and symptoms of respiratory tract infection. The following virus types, subtypes, and bacteria are identified using the ePlex…
Read the full statement (411 words)
The ePlex® Respiratory Pathogen (RP) Panel is a multiplexed nucleic acid in vitro diagnostic test intended for use on the ePlex® Instrument for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals exhibiting signs and symptoms of respiratory tract infection.
The following virus types, subtypes, and bacteria are identified using the ePlex RP Panel:
adenovirus, coronavirus, human metapneumovirus, human rhinovirus/enterovirus, influenza A,
influenza A H1, influenza A H1-2009, influenza A H3, influenza B, parainfluenza virus 1,
parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus (RSV)
A, respiratory syncytial virus (RSV) B, Chlamydia pneumoniae, and Mycoplasma pneumoniae.
The detection and identification of specific viral and bacterial nucleic acids from individuals
exhibiting signs and/or symptoms of respiratory tract infection aids in the diagnosis of respiratory
infection when used in conjunction with other clinical and epidemiological information. The results
of this test should not be used as the sole basis for diagnosis, treatment, or other patient management
decisions.
Negative results in the setting of a respiratory illness may be due to infection with pathogens that are
not detected by this test, or lower respiratory tract infection that may not be detected by a
nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms;
the organism(s) detected by the ePlex RP Panel may not be the definite cause of disease. Additional
laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be
necessary when evaluating a patient with possible respiratory tract infection.
Due to the genetic similarity between human rhinovirus and enterovirus, the ePlex RP Panel cannot
reliably differentiate them. If differentiation is required, an ePlex RP Panel positive human
rhinovirus/enterovirus result should be followed-up using an alternative method (e.g., cell culture or
sequence analysis).
Performance characteristics for influenza A were established when influenza A H1-2009 and A H3
were the predominant influenza A viruses in circulation. Performance of detecting influenza A may
vary if other influenza A strains are circulating or a novel influenza A virus emerges. 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
departments 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/K163636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163636: ePlex Respiratory Pathogen Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163636
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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