# K221925: ID Now Covid-19 2.0

- Pathway: 510(k) (Dual Track)
- Applicant: Abbott Diagnostics Scarborough, Inc.
- Decided: Aug 10, 2023 after 405 days
- Product code: QWR (Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings)
- Device class: 2
- Regulation: 21 CFR 866.3982
- Recalls of this device: 2 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 5.

## Most influential descendants
- K223783: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (2023), 1 descendant of its own
- K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 (2026), 0 descendants of its own
- K243346: cobas liat SARS-CoV-2 v2 nucleic acid test (2025), 0 descendants of its own

## Recalls of this device
- Mar 4, 2025 · Class II · Z-1571-2025: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Mar 4, 2025 · Class II · Z-1574-2025: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

## Indications for use
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 co-infection 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/K221925
Methodology: https://510kreport.com/methodology