510(k) · Cleared
ClearedElvis HSV ID/Typing Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Cleared on Nov 18, 1997 after a 203-day review. The FDA summary names its predicate without a number. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Nov 18, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- GQN
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK100336 Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010
- Descendant · 2 generations on · 2 of its ownK140198 Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK142738 artus HSV-1/2 QS-RGQ MDx KitQiagen · 2014
- Descendant · 2 generations on · 1 of its ownK111951 Isoamp HSV AssayBiohelix Corporation · 2011
- Descendant · 3 generations on · 0 of its ownK172509 Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2…3 generations on · 2015
Most influential descendants
Showing 5 of 9 · See all- K100336Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010 · cites it directly7descendants
- K140198Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014 · 2 generations on2descendants
- K142738artus HSV-1/2 QS-RGQ MDx KitQiagen · 2014 · 2 generations on1descendant
- K111951Isoamp HSV AssayBiohelix Corporation · 2011 · 2 generations on1descendant
- K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971662 | Elvis HSV ID/Typing Test System | Diagnostic Hybrids, Inc. | 1997 | — |
| +1 | K100336 | Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711 | Eragen Biosciences | 2010 | — |
| +2 | 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 | — |
| +2 | K111951 | Isoamp HSV Assay | Biohelix Corporation | 2011 | — |
| +3 | K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test | Vela Diagnostics USA, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 1 |
| 2018 | 1 | 0 |
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
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.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100336 (Eragen Biosciences, 2010) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GQN devicesGQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GQN
2in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GQN
Too few GQN 510(k)s in any year since 2007 to give a median.
Recalls per year · GQN
No recall names GQN since 2007.
Adverse event reports per year · GQN
No MAUDE report names GQN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ELVIS™ HSV ID/Typing Test System is a qualitative test indicated for use in the isolation and identification of HSV from lesions and body fluids suspected of containing viable HSV-1 and/or HSV-2. Both serotypes have been isolated from various parts of the body, particularly when HSV-associated disease is indicated. Performance of this assay has not been established for use with antiviral therapy or prenatal monitoring.
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/K971662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971662: Elvis HSV ID/Typing Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971662
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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