FDA product code SEP: Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
SEP is the FDA product code for device for home collection and transport of vaginal specimens by lay users for use in an approved hpv molecular assay. It is a Class II device, regulated under 21 CFR 866.2920 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under SEP, 1 in the last five years. The average 510(k) review took 71 days (median 71); 71 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated.
Classification
| Field | Value |
|---|---|
| Device name | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.2920 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for SEP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 71 |
Compare with all 510(k) review times · Search every SEP clearance
Top SEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 1 | 2026-04-02 |
Most recent SEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260184 | Becton, Dickinson and Company | Onclarity Self-Collection Kit | 2026-04-02 | 71 |
Recalls for SEP devices
openFDA lists no recalls for product code SEP.
Frequently asked questions
What is FDA product code SEP?
SEP is the FDA product code for device for home collection and transport of vaginal specimens by lay users for use in an approved hpv molecular assay. It is a Class II device, regulated under 21 CFR 866.2920 and reviewed by the Microbiology panel.
What device class is SEP?
Class II, regulation 21 CFR 866.2920. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEP?
Across 1 cleared submissions the average was 71 days from receipt to decision (median 71).
Which companies have the most SEP clearances?
Becton, Dickinson and Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEP
- Run a recall and safety report across every SEP manufacturer
- Watch product code SEP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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