FDA product code QYA: System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
QYA is the FDA product code for system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home. It is a Class II device, regulated under 21 CFR 866.3385 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QYA, 1 in the last five years. The average 510(k) review took 90 days (median 90); 90 days on average over the last three years. 1 De Novo request was granted under it.
Definition
This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.
Classification
| Field | Value |
|---|---|
| Device name | System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home |
| Device class | Class II |
| Regulation | 21 CFR 866.3385 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QYA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every QYA clearance
Top QYA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Molecular | 1 | 2025-01-30 |
Most recent QYA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243410 | Abbott Molecular | simpli-COLLECT STI Test | 2025-01-30 | 90 |
Recalls for QYA devices
openFDA lists no recalls for product code QYA.
Frequently asked questions
What is FDA product code QYA?
QYA is the FDA product code for system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home. It is a Class II device, regulated under 21 CFR 866.3385 and reviewed by the Microbiology panel.
What device class is QYA?
Class II, regulation 21 CFR 866.3385. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYA?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most QYA clearances?
Abbott Molecular (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYA
- Run a recall and safety report across every QYA manufacturer
- Watch product code QYA 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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