510(k) · Cleared
ClearedVELO Respiratory Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lex Diagnostics Limited · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Feb 13, 2026 as substantially equivalent to K223591 (Roche Molecular Systems, Inc., 2023) after a 252-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Feb 13, 2026
- Review
- 252 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 2 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 1 generation backK223591 cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the…Roche Molecular Systems, Inc. · 2023
- This deviceK251742 VELO Respiratory TestLex Diagnostics Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −1 | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®… | Roche Molecular Systems, Inc. | 2023 | — |
| 0 (this device) | K251742 | VELO Respiratory Test | Lex Diagnostics Limited | 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 |
|---|---|---|---|
| * | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemSummary page 5…n in a multi-target test. (21 CFR § 866.3981) Product Code: QOF Predicate Device: cobas® SARS-CoV-2 & Influenza A/B for use on the cobas Liat System (K223591) DEVICE DESCRIPTION The VELO System is comprised of a single-use VELO Respiratory Test, and a reusable VELO Instrument:… | 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)
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 2.6 years on median.
- None of the 2 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 VELO Respiratory Test is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test performed on the VELO 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 virus nucleic acid in anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract…
Read the full statement (196 words)
The VELO Respiratory Test is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction
(RT-PCR) test performed on the VELO 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 virus
nucleic acid in anterior nasal swab (ANS) 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 VELO Respiratory 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 ANS specimens during the acute
phase of infection.
Positive results do not rule out co-infection with other organisms. The agent(s) detected by the VELO Respiratory 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/K251742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251742: VELO Respiratory Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251742
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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