De Novo · Granted
GrantedLyra Direct Strep Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Granted on Apr 16, 2014 as a new device type through De Novo after a 22-day review. 1 of the 24 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Apr 16, 2014
- Review
- 22 days
- Class
- Class II
- Product code
- PGX
- Recalls
- None
23 later devices descend from it, 6 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- This deviceDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
- Descendant · cites it directly · 8 of its ownK141757 Alere I Strep aAlere Scarborough, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK141338 Liat Strep a AssayIquum, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK151690 Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK200065 cobas Influenza A/B Nucleic acid test for use on the cobas Liat…Roche Molecular Systems, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK173653 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control…Alere Scarborough, Inc. · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K143651 Simplexa Group A Strep Direct, Simplexa Group A…cites it directly · 2015
Most influential descendants
Showing 5 of 23 · See all- K141757Alere I Strep aAlere Scarborough, Inc. · 2015 · cites it directly8descendants
- K141338Liat Strep a AssayIquum, Inc. · 2014 · cites it directly8descendants
- K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 2015 · 2 generations on4descendants
- K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc. · 2020 · 2 generations on3descendants
- K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140005 | Lyra Direct Strep Assay | Quidel Corporation | 2014 | — |
| +1 | K141757 | Alere I Strep a | Alere Scarborough, Inc. | 2015 | — |
| +1 | K141338 | Liat Strep a Assay | Iquum, Inc. | 2014 | — |
| +2 | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015 | — |
| +2 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas… | Roche Molecular Systems, Inc. | 2020 | — |
| +2 | K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 4 | 1 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 PGX device
- #1 K260047 cobas Strep A Nucleic acid test for use on the…score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (23)
See all 236 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K141757 (Alere Scarborough, Inc., 2015) has gone furthest, with 8 descendants of its own.
How does its category compare?
All PGX devicesPGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PGX
85in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGX
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGX
1in 2022
MAUDE reports naming product code PGX, 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 | 3 | — | 0 | 0 |
| 2015 | 3 | 85 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/DEN140005 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140005: Lyra Direct Strep Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026