FDA product code QMA: Blood Collection Device For Cell-Free Nucleic Acid
QMA is the FDA product code for blood collection device for cell-free nucleic acid. It is a Class II device, regulated under 21 CFR 862.1676 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under QMA, 1 in the last five years. The average 510(k) review took 406 days (median 406); 406 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.
Classification
| Field | Value |
|---|---|
| Device name | Blood Collection Device For Cell-Free Nucleic Acid |
| Device class | Class II |
| Regulation | 21 CFR 862.1676 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QMA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 406 |
Compare with all 510(k) review times · Search every QMA clearance
Top QMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck, Inc. | 1 | 2024-07-26 |
Most recent QMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231776 | Streck, Inc. | Cell-Free DNA BCT | 2024-07-26 | 406 |
Recalls for QMA devices
openFDA lists no recalls for product code QMA.
Frequently asked questions
What is FDA product code QMA?
QMA is the FDA product code for blood collection device for cell-free nucleic acid. It is a Class II device, regulated under 21 CFR 862.1676 and reviewed by the Clinical Chemistry panel.
What device class is QMA?
Class II, regulation 21 CFR 862.1676. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMA?
Across 1 cleared submissions the average was 406 days from receipt to decision (median 406).
Which companies have the most QMA clearances?
Streck, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QMA
- Run a recall and safety report across every QMA manufacturer
- Watch product code QMA 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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