510(k) · Cleared
ClearedCDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centers For Disease Control and Prevention (CDC) · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Cleared on Jun 30, 2016 as substantially equivalent to K140851 (Centers for Disease Control and Prevention, 2014) after a 24-day review. Its family tree reaches back 7 generations to 2006. 8 later devices descend from it.
- Decided
- Jun 30, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- OZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN060008 (2006). 8 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 7 generations backDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- 6 generations backK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- 5 generations backK101564 CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010
- 4 generations backK111507 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2011
- 3 generations backK130551 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2013
- 2 generations backK132508 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2013
- 1 generation backK140851 Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time…Centers for Disease Control and Prevention · 2014
- This deviceK161556 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel…Centers For Disease Control and Prevention (CDC) · 2016
- Descendant · cites it directly · 7 of its ownK172091 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel…Centers for Disease Control and Prevention · 2017
- Descendant · 2 generations on · 6 of its ownK181736 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel…Centers For Disease Control and Prevention (CDC) · 2018
- Descendant · 2 generations on · 5 of its ownK190302 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel…Centers for Disease Control and Prevention · 2019
- Descendant · 3 generations on · 2 of its ownK243931 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel…Centers for Disease Control and Prevention · 2025
- Descendant · 4 generations on · 1 of its ownK243274 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel…Centers for Disease Control and Prevention · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention · 2017 · cites it directly7descendants
- K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…Centers For Disease Control and Prevention (CDC) · 2018 · 2 generations on6descendants
- K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention · 2019 · 2 generations on5descendants
- K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention · 2025 · 3 generations on2descendants
- K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2006 | — |
| −6 | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | 2008 | — |
| −5 | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | 2010 | — |
| −4 | K111507 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2011 | — |
| −3 | K130551 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | — |
| −2 | K132508 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | — |
| −1 | K140851 | Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR… | Centers for Disease Control and Prevention | 2014 | — |
| 0 (this device) | K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A… | Centers For Disease Control and Prevention (CDC) | 2016 | — |
| +1 | K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B… | Centers for Disease Control and Prevention | 2017 | — |
| +2 | K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B… | Centers For Disease Control and Prevention (CDC) | 2018 | — |
| +2 | K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B… | Centers for Disease Control and Prevention | 2019 | — |
| +3 | K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B… | Centers for Disease Control and Prevention | 2025 | — |
| +4 | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B… | Centers for Disease Control and Prevention | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K140851 | Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelSummary page 6…iagnostic Panel, Influenza A Subtyping Kit III. PREDICATE DEVICE CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (K140851) IV. DEVICE DESCRIPTION The CDC Human Influenza Real-Time RT-PCR Diagnostic Panel Influenza A Subtyping Kit is a re… | 2014 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit… | 2017 | 7 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K172091 (Centers for Disease Control and Prevention, 2017) has gone furthest, with 7 descendants of its own.
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. 2016, 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 Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument in conjunction with clinical and epidemiological information: • For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper…
Read the full statement (362 words)
The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument in conjunction with clinical and epidemiological information:
• For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture;
• To provide epidemiologic information for surveillance of circulating influenza viruses.
Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
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 unless a BSL 3E facility is available to receive and culture specimens.
All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161556: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161556
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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