510(k) · Cleared
Clearedcobas HSV 1 and 2 Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Cleared on Jun 1, 2015 as substantially equivalent to K103798 (Becton, Dickinson & CO, 2011) after an 83-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Jun 1, 2015
- Review
- 83 days
- Class
- Class II
- Product code
- OQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K103798 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK103798 BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified Dna AssaysBecton, Dickinson & CO · 2011
- This deviceK150617 cobas HSV 1 and 2 TestRoche Molecular Systems, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K103798 | BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified Dna Assays | Becton, Dickinson & CO | 2011 | — |
| 0 (this device) | K150617 | cobas HSV 1 and 2 Test | Roche Molecular Systems, Inc. | 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 |
|---|---|---|---|
| * | K103798 | BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified Dna AssaysSummary page 4…: Herpes Simplex Virus Nucleic Acid Amplification Assay BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Predicate Devices Amplified DNA Assays (K103798) Branchburg: 2243471 Establishment Pleasanton: 3004141078 Registration Indianapolis… | 2011 |
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 K103798.
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 cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital…
Read the full statement (120 words)
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Box warning:
Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150617: cobas HSV 1 and 2 Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150617
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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