510(k) · Cleared
Recalled · Class II · 2025ID Now Covid-19 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diagnostics Scarborough, Inc. · QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Cleared on Aug 10, 2023 as substantially equivalent to DEN220039 (Quidel Corporation, 2023) after a 405-day review. Its family tree reaches back 1 generation to 2023. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 10, 2023
- Review
- 405 days
- Class
- Class II
- Product code
- QWR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220039 (2023). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- This deviceK221925 ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK223783 cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW…Abbott Diagnostics Scarborough, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243346 cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023 · cites it directly1descendant
- K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc. · 2026 · cites it directly0descendants
- K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023 | — |
| 0 (this device) | K221925 | ID Now Covid-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2023 | — |
| +1 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2023 | — |
| +1 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026 | — |
| +2 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QWR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QWR device
- #1 K243346 cobas liat SARS-CoV-2 v2 nucleic acid testscore 9.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetSummary page 5…ID NOW COVID-19 2.0 510(K) SUMMARY PANEL Microbiology (83) PREDICATE DEVICE Sofia 2 SARS Antigen+ FIA, DEN220039 DEVICE DESCRIPTION ID NOW COVID-19 2.0 is a rapid, instrument-based isothermal test for the qualitative detection of nucleic aci… | 2023 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2025 | Class II | Z-1571-2025 | Process change control | 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 | Process change control | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QWR devicesQWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWR
Too few QWR 510(k)s in any year since 2007 to give a median.
Recalls per year · QWR
No recall names QWR since 2007.
Adverse event reports per year · QWR
25in 2025
MAUDE reports naming product code QWR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 90 |
| 2025 | 1 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (200 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221925: ID Now Covid-19 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026