FDA product code QSA: Circulating Tumor Cell (Ctc) Enrichment Device
QSA is the FDA product code for circulating tumor cell (ctc) enrichment device. It is a Class II device, regulated under 21 CFR 866.6110 and reviewed by the Pathology panel. Devices under QSA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.
Classification
| Field | Value |
|---|---|
| Device name | Circulating Tumor Cell (Ctc) Enrichment Device |
| Device class | Class II |
| Regulation | 21 CFR 866.6110 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Recalls for QSA devices
openFDA lists no recalls for product code QSA.
Frequently asked questions
What is FDA product code QSA?
QSA is the FDA product code for circulating tumor cell (ctc) enrichment device. It is a Class II device, regulated under 21 CFR 866.6110 and reviewed by the Pathology panel.
What device class is QSA?
Class II, regulation 21 CFR 866.6110. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QSA
- Run a recall and safety report across every QSA manufacturer
- Watch product code QSA 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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