# K141458: Simplexa HSV 1&2 Direct/Positive Control Pack

- Pathway: 510(k) (Special)
- Applicant: Focus Diagnostics
- Decided: Jul 1, 2014 after 29 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: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130049 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130049: Simplexa HSV 1&2 Direct, Focus Diagnostics (2014). Our reading of the summary gave K133621, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130049, Simplexa HSV 1&2 Direct (Focus Diagnostics), granted Mar 21, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Recalls of this device
- May 12, 2020 · Class II · Z-2547-2020: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
- Feb 10, 2016 · Class I · Z-1272-2016: Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kit

## Indications for use
The Focus Diagnostics SimplexaTM HSV I & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV- I and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-l and HSV-2 infections of the CNS. Negative results do not preclude HSV- I or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use as a donor screening test. The assay is for professional use only. The SimplexaTM HSV I & 2 Positive Control Pack is intended to be used as a control with the SimplexaTM HSV I & 2 Direct kit. This control is not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K141458
Methodology: https://510kreport.com/methodology