# K250273: BinaxNOW COVID-19 Ag Card

- Pathway: 510(k) (Dual Track)
- Applicant: Abbott Diagnostics Scarborough, Inc.
- Decided: Jun 13, 2025 after 134 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: 2 generations back to DEN220039 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231187: Nano-Check™ COVID-19 Antigen Test, Nano-Ditech Corporation (2024) Summary page 5.

## Indications for use
The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). 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 BinaxNOW COVID-19 Ag Card and followed up with a molecular test. A negative test is presumptive and does not preclude SARS-CoV-2 infection; 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 from November 2020 to July 2022, when SARS-COV-2 Delta and Omicron were dominant. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

Source page: https://510kreport.com/device/K250273
Methodology: https://510kreport.com/methodology