# K100336: Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711

- Pathway: 510(k) (Traditional)
- Applicant: Eragen Biosciences
- Decided: May 12, 2010 after 96 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
Longest line of descent: 1 generation back to K971662 (1997). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971662: Elvis HSV ID/Typing Test System, Diagnostic Hybrids, Inc. (1997) Summary page 1.

## Most influential descendants
- K140198: Imdx HSV-1/2 for Abbott M2000 (2014), 2 descendants of its own
- K142738: artus HSV-1/2 QS-RGQ MDx Kit (2014), 1 descendant of its own
- K111951: Isoamp HSV Assay (2011), 1 descendant of its own
- K172509: Sentosa SA201 HSV 1/2 Qualitative PCR Test (2018), 0 descendants of its own
- K150962: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (2015), 0 descendants of its own

## Indications for use
The MultiCode®-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 (HSV 1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 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) or 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/K100336
Methodology: https://510kreport.com/methodology