FDA product code OUY: Trichomonas Vaginalis Nucleic Acid Amplification Test System
OUY is the FDA product code for trichomonas vaginalis nucleic acid amplification test system. It is a Class II device, regulated under 21 CFR 866.3860 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under OUY, 1 in the last five years, from 6 different applicants. The average 510(k) review took 172 days (median 128). 1 De Novo request was granted under it. FDA has posted 4 recalls for OUY devices, 3 initiated in the last five years.
Definition
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
Classification
| Field | Value |
|---|---|
| Device name | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Device class | Class II |
| Regulation | 21 CFR 866.3860 |
| Review panel | MI — Microbiology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for OUY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 103 |
| 2023 | 1 | 182 |
Compare with all 510(k) review times · Search every OUY clearance
Top OUY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 2 | 2019-01-08 |
| Cepheid | 2 | 2016-08-29 |
| Quidel Corporation | 2 | 2016-08-15 |
| Hologic, Inc. | 1 | 2023-11-06 |
| Becton, Dickinson & CO | 1 | 2013-08-23 |
1 more applicants have OUY clearances. See the full list in Caduvo.
Most recent OUY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231316 | Hologic, Inc. | Aptima Trichomonas vaginalis Assay | 2023-11-06 | 182 |
| K182692 | Becton, Dickinson and Company | BD MAX CTGCTV2, BD MAX System | 2019-01-08 | 103 |
| K151589 | Becton, Dickinson and Company | BD MAX CT/GC/TV, BD MAX INSTRUMENT | 2016-09-06 | 452 |
| K161619 | Cepheid | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems | 2016-08-29 | 77 |
| K161182 | Quidel Corporation | Solana Trichomonas Assay | 2016-08-15 | 110 |
Recalls for OUY devices
4 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code OUY?
OUY is the FDA product code for trichomonas vaginalis nucleic acid amplification test system. It is a Class II device, regulated under 21 CFR 866.3860 and reviewed by the Microbiology panel.
What device class is OUY?
Class II, regulation 21 CFR 866.3860. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUY?
Across 9 cleared submissions the average was 172 days from receipt to decision (median 128).
Which companies have the most OUY clearances?
Becton, Dickinson and Company (2); Cepheid (2); Quidel Corporation (2); Hologic, Inc. (1); Becton, Dickinson & CO (1).
Have OUY devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code OUY
- Run a recall and safety report across every OUY manufacturer
- Watch product code OUY 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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