510(k) · Cleared
ClearedRamp Influenza a/B Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Response Biomedical Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Apr 16, 2008 as substantially equivalent to K062109 (Binax, Inc., 2006) after a 310-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Apr 16, 2008
- Review
- 310 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001364 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
- 1 generation backK062109 Binaxnow Influenza a & B TestBinax, Inc. · 2006 · Recalled
- This deviceK071591 Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
- Descendant · cites it directly · 0 of its ownK093116 Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp. · 2009
Most influential descendants
Showing 1 of 1 · See all- K093116Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001364 | BD Directigen Flu a+B | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000 | — |
| −1 | K062109 | Binaxnow Influenza a & B Test | Binax, Inc. | 2006 | 2 |
| 0 (this device) | K071591 | Ramp Influenza a/B Assay | Response Biomedical Corp. | 2008 | — |
| +1 | K093116 | Modification to: Ramp Influenza a/B Assay | Response Biomedical Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 PSZ? 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 PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 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 |
|---|---|---|---|
| * | K062109 | Binaxnow Influenza a & B TestSummary page 1…uct Code: GNX Panel: Microbiology Predicate Device: Immunoassay: BinaxNOW® Influenza A & B Test, (K062109), which is currently marketed by Binax, Inc. Intended Use: The RAMP® Influenza A/B Assa… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093116 | Modification to: Ramp Influenza a/B Assay | 2009 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K093116 (Response Biomedical Corp., 2009) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062109.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The RAMP® Influenza A/B Assay is a qualitative immunochromatographic assay used to identify the presence of Influenza A and Influenza B nucleoprotein antigens in nasal wash, nasal aspirate, nasopharyngeal aspirate, and nasopharyngeal swab specimens from symptomatic patients. It is an in vitro diagnostic assay that aids in the rapid differential diagnosis of influenza viral infections in symptomatic patients. A negative test is presumptive and it is…
Read the full statement (129 words)
The RAMP® Influenza A/B Assay is a qualitative immunochromatographic assay used to identify the presence of Influenza A and Influenza B nucleoprotein antigens in nasal wash, nasal aspirate, nasopharyngeal aspirate, and nasopharyngeal swab specimens from symptomatic patients. It is an in vitro diagnostic assay that aids in the rapid differential diagnosis of influenza viral infections in symptomatic patients. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
The test performance characteristics for Influenza B were established primarily with retrospective, frozen specimens. Users may wish to further evaluate the sensitivity performance of this test for Influenza B using fresh samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071591: Ramp Influenza a/B Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071591
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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