Nano-Check RSV Test
FDA 510(k) K240280 · Nano-Ditech Corporation
510(k) numberK240280
Submission
- Device name
- Nano-Check RSV Test
- Applicant
- Nano-Ditech Corporation
Cranbury, NJ, US - Received
- February 1, 2024
- Decision date
- July 30, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 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 |
| 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 |
| K091235 | Ramp RSV AssayGQG · Traditional | Response Biomedical Corp. | 07/24/2009SE |
| K070747 | Quick Vue RSV Test, Models 20193, 20199GQG · Traditional | Quidel Corp. | 04/23/2007SE |
More from Quidel Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252283 | Nano-Check Influenza A+B TestPSZ · Dual Track | 01/15/2026SE |
| K243561 | Nano-Check Influenza+COVID-19 Dual TestSCA · Dual Track | 06/17/2025SE |
| K231187 | Nano-Check COVID-19 Antigen TestQVF · Traditional | 01/23/2024SE |
| K102441 | Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and MyoglobinMMI · Special | 10/20/2010SE |
| K102131 | Nano-Check Ami Ctni Cardiac Marker TestMMI · Special | 10/20/2010SE |
| K050975 | Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB…MMI · Traditional | 03/02/2006SE |
| K050594 | Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…LDJ · Traditional | 05/15/2005SE |
Questions and answers
When was Nano-Check RSV Test cleared by the FDA?
Nano-Check RSV Test (K240280) received a 510(k) decision of Substantially Equivalent on July 30, 2024, 180 days after the submission was received.
What is the product code of K240280?
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.