Ramp RSV Assay
FDA 510(k) K091235 · Response Biomedical Corp.
510(k) numberK091235
Submission
- Device name
- Ramp RSV Assay
- Applicant
- Response Biomedical Corp.
Vancouver, B.C, CA - Received
- April 27, 2009
- Decision date
- July 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code GQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid TestGQG · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 01/30/2026SE |
| K240280 | Nano-Check RSV TestGQG · Dual Track | Nano-Ditech Corporation | 07/30/2024SE |
| K162911 | Sofia RSV FIA on Sofia 2 analyzerGQG · Traditional | Quidel Corporation | 02/22/2017SE |
| K133140 | BD Veritor System for the Rapid Detection of RSVGQG · Special | Becton, Dickinson & CO | 11/15/2013SE |
| K132456 | BD Veritor (TM) System for Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 11/07/2013SE |
| K130398 | Sofia(R) RSV FiaGQG · Traditional | Quidel Corp. | 08/13/2013SE |
| K121633 | BD Veritor(Tm) System for the Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 09/18/2012SE |
| K101918 | Quickvue RSV 10GQG · Traditional | Quidel Corp. | 09/24/2010SE |
| K101514 | BD Directigen Ez RSVGQG · Traditional | Becton, Dickinson & CO | 07/09/2010SE |
| K070747 | Quick Vue RSV Test, Models 20193, 20199GQG · Traditional | Quidel Corp. | 04/23/2007SE |
More from Quidel Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K093116 | Modification to: Ramp Influenza A/B AssayPSZ · Special | 10/21/2009SE |
| K063662 | Ramp Nt-Probnp AssayNBC · Traditional | 07/21/2008SE |
| K071591 | Ramp Influenza A/B AssayPSZ · Traditional | 04/16/2008SE |
| K033747 | Ramp Ck-Mb AssayJHX · Traditional | 05/17/2004SE |
| K033745 | Ramp Troponin I AssayMMI · Traditional | 05/17/2004SE |
| K012040 | Ramp Myoglobin AssayDDR · Traditional | 12/18/2001SE |
Questions and answers
When was Ramp RSV Assay cleared by the FDA?
Ramp RSV Assay (K091235) received a 510(k) decision of Substantially Equivalent on July 24, 2009, 88 days after the submission was received.
What is the product code of K091235?
The FDA product code is GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, a Class I (low risk) device regulated under 21 CFR 866.3480.