# K111527: Multicode-RTX Herpes Simplex Virus 1 & 2 Kit

- Pathway: 510(k) (Traditional)
- Applicant: Eragen Biosciences, Inc.
- Decided: Aug 3, 2011 after 63 days
- Product code: OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MultiCodeo-RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSVI &2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV- I or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection. Warning: The device is not FDA cleared for the use with cerebral spinal fluid (CSF) Ior any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.

Source page: https://510kreport.com/device/K111527
Methodology: https://510kreport.com/methodology