510(k) · Cleared
Recalled · Class II · 2025DASH® SARS-CoV-2 & Flu A/B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuclein, LLC · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Dec 20, 2024 as substantially equivalent to K230719 (Biofire Diagnostics, LLC, 2023) after a 196-day review. Its family tree reaches back 3 generations to 2021. It has been recalled 3 times.
- Decided
- Dec 20, 2024
- Review
- 196 days
- Class
- Class II
- Product code
- QOF
- Recalls
- 3
- 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 backK213954 BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics · 2023
- 1 generation backK230719 BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC · 2023
- This deviceK241652 DASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC · 2024
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 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | Biofire Diagnostics | 2023 | — |
| −1 | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Biofire Diagnostics, LLC | 2023 | — |
| 0 (this device) | K241652 | DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC | 2024 | — |
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 |
|---|---|---|---|
| * | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniSummary page 5…Sars-Cov-2 And Other Microbial Agents NSU: Instrumentation For Clinical Multiplex Test Systems Predicate Device: K230719: BioFire SPOTFIRE Respiratory Panel Mini Classification Code: QOF Regulation:… | 2023 |
| † | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2025 | Class II | Z-3164-2026 | Process control | Due to a software issue |
| Jun 25, 2025 | Class II | Z-2274-2025 | Process control | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) |
| Jun 25, 2025 | Class II | Z-2861-2026 | Process control | Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K230719.
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. 2024, 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 DASH® SARS-CoV-2 & Flu A/B Test is a rapid reverse transcription polymerase chain reaction (RT-PCR) assay performed on the DASH Rapid PCR Instrument and is intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus ribonucleic acid (RNA) in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test is intended to aid in the…
Read the full statement (149 words)
The DASH® SARS-CoV-2 & Flu A/B Test is a rapid reverse transcription polymerase chain reaction (RT-PCR) assay performed on the DASH Rapid PCR Instrument and is intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus ribonucleic acid (RNA) in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans in conjunction with other clinical, epidemiologic and laboratory findings.
Positive results of a specific target are indicative of the presence of that viral RNA and may not be the definite cause of disease. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241652: DASH® SARS-CoV-2 & Flu A/B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241652
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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