510(k) · Cleared
ClearedSeegene Anyplex II HSV-1/2 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seegene · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Cleared on Feb 13, 2015 as substantially equivalent to K140198 (Intelligent Medical Devices, Inc., 2014) after a 191-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Feb 13, 2015
- Review
- 191 days
- Class
- Class II
- Product code
- OQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971662 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
- 2 generations backK100336 Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010
- 1 generation backK140198 Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014
- This deviceK142156 Seegene Anyplex II HSV-1/2 AssaySeegene · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971662 | Elvis HSV ID/Typing Test System | Diagnostic Hybrids, Inc. | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | K142156 | Seegene Anyplex II HSV-1/2 Assay | Seegene | 2015 | — |
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.
Planning a device in OQO? 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
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 | Decided |
|---|---|---|---|
| * | K140198 | Imdx HSV-1/2 for Abbott M2000Summary page 5…x™ II HSV-1/2 Assay Abbott m2000 Assay (New Device) (Predicate Device) 510(k) K140198 K142156 Regulation 21 CFR 866.3305 21 CFR 866.3305 Product Code… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K140198.
How does its category compare?
All OQO devicesOQO Herpes Simplex Virus Nucleic Acid Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OQO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OQO
140in 2015
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 81 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 87 | 0 | 0 |
| 2015 | 3 | 140 | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AnyplexTM II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA from female skin lesions from anogenital sites. The test is intended for use as an aid in the diagnosis of anogenital HSV infection in symptomatic patients.
WARNING: The AnyplexTM II HSV-1/2 Assay is not indicated for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142156: Seegene Anyplex II HSV-1/2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142156
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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