510(k) · Cleared

Cleared

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

K100336510(k) TraditionalCleared May 12, 201096-day reviewClass II21 CFR 866.3305

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eragen Biosciences · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

Cleared on May 12, 2010 as substantially equivalent to K971662 (Diagnostic Hybrids, Inc., 1997) after a 96-day review. Its family tree reaches back 1 generation to 1997. 1 of the 9 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.

Decided: May 12, 2010
Review: 96 days
Class: Class II
Product code: OQO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971662 (1997). 7 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
This deviceK100336 Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010
Descendant · cites it directly · 2 of its ownK140198 Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014
Descendant · cites it directly · 1 of its ownK142738 artus HSV-1/2 QS-RGQ MDx KitQiagen · 2014
Descendant · cites it directly · 1 of its ownK111951 Isoamp HSV AssayBiohelix Corporation · 2011
Descendant · 2 generations on · 0 of its ownK172509 Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 2015 · Recalled (Class I)

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011high 3 (2014) · low 0 (2012)2026

Class I recalls in this family

K150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2…2 generations on · 2015

Most influential descendants

Showing 5 of 7 · See all

K140198Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014 · cites it directly2descendants
K142738artus HSV-1/2 QS-RGQ MDx KitQiagen · 2014 · cites it directly1descendant
K111951Isoamp HSV AssayBiohelix Corporation · 2011 · cites it directly1descendant
K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. · 2018 · 2 generations on0descendants
K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971662	Elvis HSV ID/Typing Test System	Diagnostic Hybrids, Inc.	1997	—
0 (this device)	K100336	Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711	Eragen Biosciences	2010	—
+1	K140198	Imdx HSV-1/2 for Abbott M2000	Intelligent Medical Devices, Inc.	2014	—
+1	K142738	artus HSV-1/2 QS-RGQ MDx Kit	Qiagen	2014	—
+1	K111951	Isoamp HSV Assay	Biohelix Corporation	2011	—
+2	K172509	Sentosa SA201 HSV 1/2 Qualitative PCR Test	Vela Diagnostics USA, Inc.	2018	—
+2	K150962	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	Focus Diagnostics	2015	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	3	0
2015	2	1
2018	1	0

FIG. 1 — Lineage of K100336, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K971662	Elvis HSV ID/Typing Test System Summary page 1 …05 3.0 Device to Which Substantial Equivalence is Claimed Diagnostic Hybrids, Inc. ELVIS® HSV ID/Typing Test System 5 10(k) Number: K97 1662 Confidential EraGen Biosciences, Inc. - 510O(k) Premarket Notification MultiCode®--RTx Heroes Simplex Vimus 1…	Diagnostic Hybrids, Inc.	1997	—

Also cleared against K971662: 1 other device →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140198	Imdx HSV-1/2 for Abbott M2000	Intelligent Medical Devices, Inc.	2014	2
K142738	artus HSV-1/2 QS-RGQ MDx Kit	Qiagen	2014	1
K111951	Isoamp HSV Assay	Biohelix Corporation	2011	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K140198 (Intelligent Medical Devices, Inc., 2014) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K971662.

How does its category compare?

All OQO devices

OQO Herpes Simplex Virus Nucleic Acid Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OQO

1in 2018

2007high 3 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQO

140in 2015

2007high 140 (2015) · low 81 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OQO

No recall names OQO since 2007.

Adverse event reports per year · OQO

1in 2025

2007high 6 (2016) · low 0 (2007)2025

MAUDE reports naming product code OQO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	3	81	0
2012	0	—	0
2013	0	—	0
2014	3	87	0
2015	3	140	0
2016	0	—	6
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	2
2025	0	—	1
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K100336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100336: Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100336

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026