# K241652: DASH® SARS-CoV-2 & Flu A/B Test

- Pathway: 510(k) (Dual Track)
- Applicant: Nuclein, LLC
- Decided: Dec 20, 2024 after 196 days
- Product code: QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN200031 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230719: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini, Biofire Diagnostics, LLC (2023) Summary page 5.

## Recalls of this device
- Oct 22, 2025 · Class II · Z-3164-2026: Due to a software issue
- Jun 25, 2025 · Class II · Z-2274-2025: 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: Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

## Indications for use
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.

Source page: https://510kreport.com/device/K241652
Methodology: https://510kreport.com/methodology