510(k) · Cleared
ClearedElvis HSV ID and D3 Typing Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Cleared on Aug 28, 2009 as substantially equivalent to K971662 (Diagnostic Hybrids, Inc., 1997) after a 73-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 28, 2009
- Review
- 73 days
- Class
- Class II
- Product code
- GQL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971662 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
- This deviceK091753 Elvis HSV ID and D3 Typing Test SystemDiagnostic Hybrids, Inc. · 2009
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) | K091753 | Elvis HSV ID and D3 Typing Test System | Diagnostic Hybrids, Inc. | 2009 | — |
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 GQL? 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 |
|---|---|---|---|
| * | K971662 | Elvis HSV ID/Typing Test SystemSummary page 1…simplex virus serological assays; Panel - Microbiology (83) Legally marketed devices to which equivalence is claimed: ELVIS®HSV ID/Typing Test System (k971662) Intended Use: The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test… | 1997 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K971662.
How does its category compare?
All GQL devicesGQL Antisera, Fluorescent, Herpesvirus Hominis 1,2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GQL
2in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GQL
Too few GQL 510(k)s in any year since 2007 to give a median.
Recalls per year · GQL
No recall names GQL since 2007.
Adverse event reports per year · GQL
1in 2009
MAUDE reports naming product code GQL, 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 | 2 | — | 0 | 1 |
| 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 ELVIS8-HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens as an aid in the diagnosis of HSV type 1 (HSV-1) and HSV type 2 (HSV-2) infections. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or use with cerebral spinal fluid specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091753 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091753: Elvis HSV ID and D3 Typing Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091753
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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