510(k) · Cleared
ClearedAptima Herpes Simplex Viruses 1 & 2 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Cleared on Jun 15, 2017 as substantially equivalent to K103798 (Becton, Dickinson & CO, 2011) after a 262-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Jun 15, 2017
- Review
- 262 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 deviceK162673 Aptima Herpes Simplex Viruses 1 & 2 AssayHologic, Inc. · 2017
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) | K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | Hologic, Inc. | 2017 | — |
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…Class II Product Code: OQO III. PREDICATE DEVICE The predicate device is the BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (K103798; cleared March 18, 2011; BD Diagnostics Systems, Sparks, MD). IV. DEVICE DESCRIPTION The Aptima Herpes Simplex Virus 1 & 2 assa… | 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. 2017, 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 Aptima Herpes Simplex Viruses 1 & 2 assay (Aptima HSV 1 & 2 assay) is an in vitro diagnostic nucleic acid amplification test (NAAT), using real time transcription-mediated amplification (TMA), for the qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) messenger RNA (mRNA) in clinician-collected swab specimens from anogenital skin lesions. The assay is intended for use with swab specimens placed in…
Read the full statement (151 words)
The Aptima Herpes Simplex Viruses 1 & 2 assay (Aptima HSV 1 & 2 assay) is an in vitro diagnostic nucleic acid amplification test (NAAT), using real time transcription-mediated amplification (TMA), for the qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) messenger RNA (mRNA) in clinician-collected swab specimens from anogenital skin lesions. The assay is intended for use with swab specimens placed in Aptima specimen transport medium (STM) or in viral transport media (VTM) that is immediately diluted into STM.
The Aptima HSV 1 & 2 assay is intended for use as an aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The Aptima HSV 1 & 2 assay is indicated for use on the Panther® system.
Warning
The Aptima HSV 1 & 2 assay is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162673: Aptima Herpes Simplex Viruses 1 & 2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162673
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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