# K150962: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics
- Decided: Aug 28, 2015 after 140 days
- Product code: OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3305
- 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: 3 generations back to K971662 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142738: artus HSV-1/2 QS-RGQ MDx Kit, Qiagen (2014) Summary page 4.

## 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
Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simples virus (HSV-1 and HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-1 or HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections. The assay is not intended for use as a screening test for the presence of HSV-1 and HSV-2 in blood or blood products. The assay is for professional use only. Simplexa™ HSV 1 & 2 Positive Control Pack The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K150962
Methodology: https://510kreport.com/methodology