510(k) Report

510(k) · Cleared

Cleared

Modification to: Ramp Influenza a/B Assay

K093116510(k) SpecialCleared Oct 21, 200919-day reviewClass II21 CFR 866.3328

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Response Biomedical Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens

Cleared on Oct 21, 2009 as substantially equivalent to K071591 (Response Biomedical Corp., 2008) after a 19-day review. Its family tree reaches back 3 generations to 2000.

Decided
Oct 21, 2009
Review
19 days
Class
Class II
Product code
PSZ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001364 (2000). No later device cites it as a predicate yet.

K001364 · BD Directigen Flu a+B · Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000K062109 · Binaxnow Influenza a & B Test · Binax, Inc. · 2006 · recalledK071591 · Ramp Influenza a/B Assay · Response Biomedical Corp. · 2008200020022004200620082010
K071591 · Ramp Influenza a/B Assay · Response Biomedical Corp. · 2008K062109 · Binaxnow Influenza a & B Test · Binax, Inc. · 2006 · recalledK001364 · BD Directigen Flu a+B · Bd Becton Dickinson Vacutainer Systems Preanalytic · 20000
  1. Root · 3 generations backK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
  2. 2 generations backK062109 Binaxnow Influenza a & B TestBinax, Inc. · 2006 · Recalled
  3. 1 generation backK071591 Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
  4. This deviceK093116 Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001364BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic2000—
−2K062109Binaxnow Influenza a & B TestBinax, Inc.20062
−1K071591Ramp Influenza a/B AssayResponse Biomedical Corp.2008—
0 (this device)K093116Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp.2009—
FIG. 1 — Lineage of K093116, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K071591Ramp Influenza a/B Assay
Summary page 1
…s: k093116. The purpose of this 510(k) submission is to provide additional Analytical Reactivity information for the currently 510(k) cleared RAMP® Influenza A/B Assay (k0715911). Establishment: Response Biomedical Corporation 1 7 8 1 - 7 5 th Avenue West Vancouver,…
Response Biomedical Corp.2008—

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 3 companies; a new generation was cleared every 1.5 years on median.
  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All PSZ devices

PSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · PSZ

2in 2025

2007: 22008: 12009: 72010: 52011: 32012: 22013: 82014: 12015: 42016: 32017: 32018: 52020: 22023: 22025: 22026 (partial year): 2
2007high 8 (2013) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSZ

28in 2018

2009: 20 days median2010: 29 days median2011: 80 days median2013: 28 days median2015: 27 days median2016: 29 days median2017: 200 days median2018: 28 days median
2007high 200 (2017) · low 20 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PSZ

1in 2022

2020: 12022: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PSZ

60in 2025

2018: 12019: 12020: 52021: 422022: 102023: 122024: 162025: 60
2007high 60 (2025) · low 0 (2007)2025

MAUDE reports naming product code PSZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
200972000
201052900
201138000
20122—00
201382800
20141—00
201542700
201632900
2017320000
201852801
20190—01
20202—15
20210—042
20220—110
20232—012
20240—016
20252—060
20262—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.

More from Response Biomedical Corp.

7 FDA decisions under this applicant name. See the company

  • K091235Ramp RSV AssayResponse Biomedical Corp. · 2009
  • K063662Ramp NT-Probnp AssayResponse Biomedical Corp. · 2008
  • K071591Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
  • K033747Ramp CK-MB AssayResponse Biomedical Corp. · 2004
  • K033745Ramp Troponin I AssayResponse Biomedical Corp. · 2004

Recent decisions in PSZ

The PSZ category page

  • K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026
  • K252283Nano-Check Influenza A+B TestNano-Ditech Corporation · 2026
  • K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025
  • K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC · 2025
  • K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd · 2023

https://510kreport.com/device/K093116 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093116: Modification to: Ramp Influenza a/B Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093116

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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