# DEN130049: Simplexa HSV 1&2 Direct

- Pathway: De Novo (Direct)
- Applicant: Focus Diagnostics
- Decided: Mar 21, 2014 after 116 days
- Product code: PGH (Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel)
- Device class: 2
- Regulation: 21 CFR 866.3307
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K250050: miDiagnostics HSV-1&2 CSF Test (2025), 0 descendants of its own
- K141458: Simplexa HSV 1&2 Direct/Positive Control Pack (2014), 0 descendants of its own

Source page: https://510kreport.com/device/DEN130049
Methodology: https://510kreport.com/methodology