# K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0

- Pathway: 510(k) (Special)
- Applicant: Abbott Diagnostics Scarborough, Inc.
- Decided: Aug 31, 2026 after 28 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to DEN070013 (2008). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232775: ID NOW Influenza A & B 2, Abbott Diagnostics Scarborough, Inc. (2023) Summary page 7.
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2, Abbott Diagnostics Scarborough, Inc. (2022) Summary page 7.
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2, Alere Scarborough, Inc. (2018) Summary page 7.
- K221925: ID Now Covid-19 2.0, Abbott Diagnostics Scarborough, Inc. (2023) Summary page 7.

## Indications for use
ID NOW Influenza A & B 2 The ID NOW Influenza A & B 2 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. ID NOW RSV The ID NOW RSV assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children <18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors. ID NOW Strep A 2 ID NOW Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections. ID NOW COVID-19 2.0 ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude coinfection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Point-of-Care settings.

Source page: https://510kreport.com/device/K262747
Methodology: https://510kreport.com/methodology