# K220963: Simplexa COVID-19 & Flu A/B Direct

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin Molecular, LLC
- Decided: Mar 17, 2023 after 350 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200031 (2021). 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)
- DEN200031: BioFire Respiratory Panel 2.1 (RP2.1), Biofire Diagnostics, LLC (2021) Summary page 4.

## Most influential descendants
- K252269: FINDER Flu A&B/SARS-CoV-2 Test (2026), 1 descendant of its own
- K261837: FINDER Flu A&B/SARS-CoV-2 Test (2026), 0 descendants of its own
- K242526: Visby Medical Respiratory Health Test (2025), 0 descendants of its own

## Indications for use
The DiaSorin Molecular Simplexa™ COVID-19 & Flu A/B Direct is a real-time RT-PCR assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection. The Simplexa™ COVID-19 & Flu A/B Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A and influenza B infection. 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. Positive results do not rule out coinfection with other organisms. Results should be combined with clinical observations, patient history, and epidemiological information. The Simplexa™ COVID-19 & Flu A/B Direct assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Source page: https://510kreport.com/device/K220963
Methodology: https://510kreport.com/methodology