# K231187: Nano-Check™ COVID-19 Antigen Test

- Pathway: 510(k) (Traditional)
- Applicant: Nano-Ditech Corporation
- Decided: Jan 23, 2024 after 272 days
- 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: 2
- Regulation: 21 CFR 866.3982
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN220039 (2023). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set, Quidel Corporation (2023) Summary page 4.

## Most influential descendants
- K253882: CorDx Tyfast COVID-19 Ag Rapid Test Rx (2026), 0 descendants of its own
- K251289: WELLlife COVID-19 Antigen Test Rx (2025), 0 descendants of its own
- K243872: BD Veritor System for SARS-CoV-2 (2025), 0 descendants of its own
- K250273: BinaxNOW COVID-19 Ag Card (2025), 0 descendants of its own

## Indications for use
The Nano-Check COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 4 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Nano-Check™ COVID-19 Antigen Test and followed up with a molecular test. The test does not differentiate between SARS-CoV or SARS-CoV-2. A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the 2022-2023 SARSCoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

Source page: https://510kreport.com/device/K231187
Methodology: https://510kreport.com/methodology