FDA product code PBA: Ecarin Clotting Time
PBA is the FDA product code for ecarin clotting time. It is a HDE device, reviewed by the Hematology panel. Devices under PBA reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure.
Classification
| Field | Value |
|---|---|
| Device name | Ecarin Clotting Time |
| Device class | HDE |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PBA devices
openFDA lists no recalls for product code PBA.
Frequently asked questions
What is FDA product code PBA?
PBA is the FDA product code for ecarin clotting time. It is a HDE device, reviewed by the Hematology panel.
What device class is PBA?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PBA
- Run a recall and safety report across every PBA manufacturer
- Watch product code PBA 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.