Nano-Check COVID-19 Antigen Test
FDA 510(k) K231187 · Nano-Ditech Corporation
Submission
- Device name
- Nano-Check COVID-19 Antigen Test
- Applicant
- Nano-Ditech Corporation
Cranbury, NJ, US - Received
- April 26, 2023
- Decision date
- January 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3982
- Specialty
- Microbiology
A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to…
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| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 09/04/2026SE |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test RxQVF · Dual Track | CorDx, Inc. | 06/01/2026SE |
| K251289 | WELLlife COVID-19 Antigen Test RxQVF · Dual Track | Guangzhou Wondfo Biotech Co., Ltd. | 10/22/2025SE |
| K243872 | BD Veritor System for SARS-CoV-2QVF · Dual Track | Becton, Dickinson and Company | 06/16/2025SE |
| K250273 | BinaxNOW COVID-19 Ag CardQVF · Dual Track | Abbott Diagnostics Scarborough, Inc. | 06/13/2025SE |
| K233358 | SCoV-2 Ag Detect Rapid TestQVF · Dual Track | InBios International, Inc. | 08/23/2024SE |
| K232377 | Healgen Rapid COVID-19 Antigen TestQVF · Traditional | Healgen Scientific,, LLC | 04/19/2024SE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | Quidel Corporation | 12/13/2023SE |
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| K050975 | Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB…MMI · Traditional | 03/02/2006SE |
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Questions and answers
When was Nano-Check COVID-19 Antigen Test cleared by the FDA?
Nano-Check COVID-19 Antigen Test (K231187) received a 510(k) decision of Substantially Equivalent on January 23, 2024, 272 days after the submission was received.
What is the product code of K231187?
The FDA product code is QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, a Class II (moderate risk) device regulated under 21 CFR 866.3982.