510(k) · Cleared
ClearedFINDER Flu A&B/SARS-CoV-2 Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baebies, Inc. · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Sep 11, 2026 as substantially equivalent to K252269 (Baebies, Inc., 2026) after a 101-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Sep 11, 2026
- Review
- 101 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 2 generations backK220963 Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC · 2023
- 1 generation backK252269 FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc. · 2026
- This deviceK261837 FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −2 | K220963 | Simplexa COVID-19 & Flu A/B Direct | Diasorin Molecular, LLC | 2023 | — |
| −1 | K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026 | — |
| 0 (this device) | K261837 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026 | — |
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 QOF? 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 QOF device
- #1 K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assayscore 17.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K252269 | FINDER Flu A&B/SARS-CoV-2 TestSummary page 6…the user and optionally printed. 5. Substantial Equivalence Information A. Predicate Device Name(s): FINDER Flu A&B/SARS-CoV-2 Test B. Predicate 510(k) Number(s): K252269 C. Comparison with Predicate(s): 340-000038 Rev 01… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QOF devicesQOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QOF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QOF
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QOF
10in 2025
MAUDE reports naming product code QOF, 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 7 | 238 | 1 | 6 |
| 2024 | 9 | 147 | 1 | 30 |
| 2025 | 13 | 178 | 1 | 10 |
| 2026 | 8 | 128 | 2 | — |
What is it indicated for?
The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test performed on the FINDER instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of…
Read the full statement (192 words)
The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test performed on the FINDER instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.
The FINDER Flu A&B/SARS-CoV-2 Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS specimens during the acute phase of infection.
Positive results do not rule out co-infection with other organisms. The agent(s) detected by the FINDER Flu A&B/SARS-CoV-2 Test may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261837: FINDER Flu A&B/SARS-CoV-2 Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261837
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026