Xprecia Prime Coagulation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230802 FDA 510(k)
- FDA Product Code
- GJS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7750 FDA 510(k)
- Regulation Number
- 864.7750 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xprecia Prime Coagulation System is a hematology test system designed for the measurement of prothrombin time and related coagulation parameters. It is a Class II medical device that has been determined to be substantially equivalent to a legally marketed predicate device.
The system is supplied for use in clinical laboratory settings and is authorized under FDA 510(k) clearance (K230802). It is intended for use by trained healthcare professionals in accordance with the manufacturer's instructions for use and applicable regulatory requirements.
Frequently asked questions
What is the Xprecia Prime Coagulation System used for?
The Xprecia Prime Coagulation System is designed for the measurement of prothrombin time and related coagulation parameters. It is intended for use in clinical laboratory settings by trained healthcare professionals to assess blood clotting function as part of hematology testing.
How is the Xprecia Prime Coagulation System supplied and intended for use?
The system is supplied for use in clinical laboratory settings and is intended for use by trained healthcare professionals in accordance with the manufacturer's instructions for use and applicable regulatory requirements. It is not intended for point-of-care or home use based on the provided data.
What regulatory authorization does the Xprecia Prime Coagulation System have?
The Xprecia Prime Coagulation System is authorized under FDA 510(k) clearance with K-number K230802. It has been determined to be substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230802 | Class II | Active |
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Manufacturer
- Manufacturer
- Universal Biosensors Pty Ltd
- FDA Applicant
- Universal Biosensors Pty, Ltd.
Sources (1)
- FDA 510(k) K230802 24 fields · synced Sep 23, 2026