FDA product code PQQ: Data Acquisition Software
PQQ is the FDA product code for data acquisition software. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Microbiology panel. Devices under PQQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PQQ devices.
Definition
Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.
Classification
| Field | Value |
|---|---|
| Device name | Data Acquisition Software |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | MI — Microbiology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for PQQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-22.
Frequently asked questions
What is FDA product code PQQ?
PQQ is the FDA product code for data acquisition software. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Microbiology panel.
What device class is PQQ?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
Have PQQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code PQQ
- Run a recall and safety report across every PQQ manufacturer
- Watch product code PQQ 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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