FDA product code QEP: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
QEP is the FDA product code for nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections. It is a Class II device, regulated under 21 CFR 866.3393 and reviewed by the Microbiology panel. FDA has cleared 23 510(k) submissions under QEP, 13 in the last five years, from 11 different applicants. The average 510(k) review took 237 days (median 171); 204 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 4 recalls for QEP devices, 4 initiated in the last five years.
Definition
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections |
| Device class | Class II |
| Regulation | 21 CFR 866.3393 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QEP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 4 | 85 |
| 2020 | 3 | 43 |
| 2021 | 3 | 482 |
| 2022 | 3 | 378 |
| 2023 | 3 | 307 |
| 2025 | 4 | 258 |
| 2026 | 3 | 151 |
Compare with all 510(k) review times · Search every QEP clearance
Top QEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 7 | 2026-07-08 |
| Hologic, Inc. | 4 | 2022-06-03 |
| Visby Medical | 2 | 2023-03-07 |
| Abbott Molecular, Inc. | 2 | 2023-03-03 |
| Binx Health, Inc. | 2 | 2020-04-27 |
6 more applicants have QEP clearances. See the full list in Caduvo.
Most recent QEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260917 | Roche Molecular Systems, Inc. | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | 2026-07-08 | 111 |
| K253756 | Roche Molecular Systems, Inc. | cobas liat CT/NG nucleic acid test | 2026-05-15 | 171 |
| K253759 | Roche Molecular Systems, Inc. | cobas liat CT/NG/MG nucleic acid test | 2026-05-15 | 171 |
| K251501 | Visby Medical, Inc. | Visby Medical Men's Sexual Health Test | 2025-10-01 | 139 |
| K243343 | Bd Integrated Diagnostic Solutions/Becton, | BD CTGCTV2 | 2025-04-22 | 179 |
Recalls for QEP devices
4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-10-31.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code QEP?
QEP is the FDA product code for nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections. It is a Class II device, regulated under 21 CFR 866.3393 and reviewed by the Microbiology panel.
What device class is QEP?
Class II, regulation 21 CFR 866.3393. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEP?
Across 23 cleared submissions the average was 237 days from receipt to decision (median 171).
Which companies have the most QEP clearances?
Roche Molecular Systems, Inc. (7); Hologic, Inc. (4); Visby Medical (2); Abbott Molecular, Inc. (2); Binx Health, Inc. (2).
Have QEP devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2024-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code QEP
- Run a recall and safety report across every QEP manufacturer
- Watch product code QEP 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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