510(k) · Cleared
ClearedSimplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin Molecular, LLC · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Oct 30, 2025 as substantially equivalent to K242465 (Hologic, Inc., 2024) after a 91-day review. Its family tree reaches back 4 generations to 2021.
- Decided
- Oct 30, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 4 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 3 generations backK222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2023 · Recalled
- 2 generations backK241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2024
- 1 generation backK242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc. · 2024
- This deviceK252387 Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™…Diasorin Molecular, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −3 | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023 | 1 |
| −2 | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024 | — |
| −1 | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. | 2024 | — |
| 0 (this device) | K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu… | Diasorin Molecular, LLC | 2025 | — |
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 |
|---|---|---|---|
| * | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assaySummary page 8…ents a comprehensive comparative analysis between the SimplexaTM COVID-19 & Flu A/B & RSV Direct assay and the Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay (FDA 510(k) K242465). The analysis is structured to fulfill the predicate device comparison requirements of 21 CFR 807.92(a)(3). Table 1 contains a… | 2024 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2025, 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 Simplexa COVID-19 / Flu A/B & RSV Direct is a real-time RT-PCR assay intended for use on the LIAISON MDX instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus and respiratory syncytial virus (RSV) in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and…
Read the full statement (254 words)
The Simplexa COVID-19 / Flu A/B & RSV Direct is a real-time RT-PCR assay intended for use on the LIAISON MDX instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus and respiratory syncytial virus (RSV) in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.
The Simplexa COVID-19 / Flu A/B & RSV Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in nasopharyngeal swab and anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.
Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the Simplexa COVID-19 / Flu A/B & RSV Direct real-time RT-PCR assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B, or RSV infection and should not be used as the sole basis for patient management decisions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252387: Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252387
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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