510(k) · Cleared
ClearedLyra Parainfluenza Virus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · OOU Parainfluenza Multiplex Nucleic Acid Assay
Cleared on Oct 9, 2014 as substantially equivalent to K091053 (Prodesse, Inc., 2009) after an 85-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Oct 9, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- OOU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN070013 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 OOU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091053 | Proparaflu+AssaySummary page 5…ew Device with Predicate Device Item Subject Device Predicate Device Lyra™ Parainfluenza (K091053) Virus Assay Prodesse… | 2009 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K091053.
How does its category compare?
All OOU devicesOOU Parainfluenza Multiplex Nucleic Acid Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OOU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OOU
Too few OOU 510(k)s in any year since 2007 to give a median.
Recalls per year · OOU
No recall names OOU since 2007.
Adverse event reports per year · OOU
No MAUDE report names OOU since 2007.
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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lyra™ Parainfluenza Virus Assay is a Real‐Time PCR assay for the qualitative detection and identification of human parainfluenza virus types 1, 2 and 3 viral RNA from nasal and nasopharyngeal swab specimens from symptomatic patients. It is intended for use as an aid in the differential diagnosis of parainfluenza virus types 1, 2 and 3. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b viruses.
Negative results do not preclude parainfluenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141927: Lyra Parainfluenza Virus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141927
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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