FDA product code OQO: Herpes Simplex Virus Nucleic Acid Amplification Assay
OQO is the FDA product code for herpes simplex virus nucleic acid amplification assay. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under OQO, from 12 different applicants. The average 510(k) review took 119 days (median 92). FDA has posted 1 recall for OQO devices.
Definition
A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
Classification
| Field | Value |
|---|---|
| Device name | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for OQO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 262 |
| 2018 | 1 | 164 |
Compare with all 510(k) review times · Search every OQO clearance
Top OQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vela Diagnostics USA, Inc. | 1 | 2018-02-01 |
| Hologic, Inc. | 1 | 2017-06-15 |
| Focus Diagnostics | 1 | 2015-08-28 |
| Roche Molecular Systems, Inc. | 1 | 2015-06-01 |
| Seegene | 1 | 2015-02-13 |
7 more applicants have OQO clearances. See the full list in Caduvo.
Most recent OQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172509 | Vela Diagnostics USA, Inc. | Sentosa SA201 HSV 1/2 Qualitative PCR Test | 2018-02-01 | 164 |
| K162673 | Hologic, Inc. | Aptima Herpes Simplex Viruses 1 & 2 Assay | 2017-06-15 | 262 |
| K150962 | Focus Diagnostics | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | 2015-08-28 | 140 |
| K150617 | Roche Molecular Systems, Inc. | cobas HSV 1 and 2 Test | 2015-06-01 | 83 |
| K142156 | Seegene | SEEGENE ANYPLEX II HSV-1/2 ASSAY | 2015-02-13 | 191 |
Recalls for OQO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-05-12.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code OQO?
OQO is the FDA product code for herpes simplex virus nucleic acid amplification assay. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is OQO?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQO?
Across 12 cleared submissions the average was 119 days from receipt to decision (median 92).
Which companies have the most OQO clearances?
Vela Diagnostics USA, Inc. (1); Hologic, Inc. (1); Focus Diagnostics (1); Roche Molecular Systems, Inc. (1); Seegene (1).
Have OQO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code OQO
- Run a recall and safety report across every OQO manufacturer
- Watch product code OQO 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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