De Novo · Granted
GrantedSimplexa HSV 1&2 Direct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics · PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Granted on Mar 21, 2014 as a new device type through De Novo after a 116-day review. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 21, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- PGH
- Recalls
- None
2 later devices descend from it, 2 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceDEN130049 Simplexa HSV 1&2 DirectFocus Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK250050 miDiagnostics HSV-1&2 CSF TestMidiagnostics NV · 2025
- Descendant · cites it directly · 0 of its ownK141458 Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 2014 · Recalled (Class I)
Class I recalls in this family
- K141458 Simplexa HSV 1&2 Direct/Positive Control Packcites it directly · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130049 | Simplexa HSV 1&2 Direct | Focus Diagnostics | 2014 | — |
| +1 | K250050 | miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV | 2025 | — |
| +1 | K141458 | Simplexa HSV 1&2 Direct/Positive Control Pack | Focus Diagnostics | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2025 | 1 | 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 PGH device
- #1 K250050 miDiagnostics HSV-1&2 CSF Testscore 10.1 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 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.
- K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K250050 (Midiagnostics NV, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PGH devicesPGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGH
Too few PGH 510(k)s in any year since 2007 to give a median.
Recalls per year · PGH
No recall names PGH since 2007.
Adverse event reports per year · PGH
No MAUDE report names PGH 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN130049 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130049: Simplexa HSV 1&2 Direct.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130049
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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