510(k) · Cleared
Recalled · Class I · 2020Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Cleared on Aug 28, 2015 as substantially equivalent to K142738 (Qiagen, 2014) after a 140-day review. Its family tree reaches back 3 generations to 1997. 1 of the 4 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 28, 2015
- Review
- 140 days
- Class
- Class II
- Product code
- OQO
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971662 (1997). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- 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 backK142738 artus HSV-1/2 QS-RGQ MDx KitQiagen · 2014
- This deviceK150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 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 | K142738 | artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | 2014 | — |
| 0 (this device) | K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Focus Diagnostics | 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.
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142738 | artus HSV-1/2 QS-RGQ MDx KitSummary page 4…n OQO Regulation Product Code ® Predicate Device OQO - artus HSV-1/2 QS-RGQ MDx Kit (K142738) Intended Use Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M I… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2020 | Class II | Z-2547-2020 | Under Investigation by firm | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| Feb 10, 2016 | Class I | Z-1272-2016 | Under Investigation by firm | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a… |
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 4.6 years on median.
- None of the 3 ancestors has a recall.
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?
Simplexa™ HSV 1 & 2 Direct The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simples virus (HSV-1 and HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-1 or HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections. The…
Read the full statement (151 words)
Simplexa™ HSV 1 & 2 Direct
The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct assay is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of herpes simples virus (HSV-1 and HSV-2) DNA present in genital lesion swabs samples from patients with signs and symptoms of HSV-1 or HSV-2 infection of the genitalia. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 genital infections.
The assay is not intended for use as a screening test for the presence of HSV-1 and HSV-2 in blood or blood products. The assay is for professional use only.
Simplexa™ HSV 1 & 2 Positive Control Pack
The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150962: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150962
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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