Identifiers
- 510(k) Number
- K093460 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 CoaguChek XS Pro System is a point-of-care diagnostic device designed for the quantitative measurement of prothrombin time (PT) in capillary blood or non-anticoagulated venous whole blood. It falls under the classification of a coagulation test system, enabling healthcare professionals to monitor anticoagulation therapy in patients taking oral anticoagulants. The system provides rapid and accurate PT results, supporting clinical decision-making in hematology settings.
This system comprises a handheld meter and disposable test strips, supplied as a single-use device for each measurement. It is intended for use in clinical environments, including hospitals, outpatient clinics, and anticoagulation management centers. The device is classified as a Class II medical device under FDA regulations (21 CFR 864.7750) and has received a Traditional 510(k) clearance. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the CoaguChek XS Pro System used for?
The CoaguChek XS Pro System is designed for quantitative measurement of prothrombin time (PT) in capillary blood or non-anticoagulated venous whole blood. It supports healthcare professionals in monitoring anticoagulation therapy for patients taking oral anticoagulants, helping to guide clinical decisions in hematology.
How is the CoaguChek XS Pro System supplied?
The system consists of a handheld meter and disposable test strips. Each test strip is intended for single-use only, ensuring accurate and reliable PT measurements per test. The strips are not reusable, and the meter is reusable for multiple tests.
Is the CoaguChek XS Pro System sterile?
The provided data does not specify whether the test strips or components of the CoaguChek XS Pro System are sterile. Users should follow manufacturer guidelines and local regulations regarding sterility for clinical use.
Can the CoaguChek XS Pro System be used in different clinical settings?
Yes, the device is intended for use in various clinical environments, including hospitals, outpatient clinics, and anticoagulation management centers. Its portability and ease of use make it suitable for point-of-care testing in these settings.
What regulatory pathway does the CoaguChek XS Pro System follow?
The CoaguChek XS Pro System has received a Traditional 510(k) clearance from the FDA, indicating it is classified as a Class II medical device under 21 CFR 864.7750. This clearance confirms its substantial equivalence to a predicate device and compliance with applicable regulations.
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. Sources consulted: CoaguChek® XS Pro system - Roche Diagnostics USA, CoaguChek® XS Pro system - Roche Diagnostics USA, ROCHE COAGUCHEK XS PRO OPERATOR'S MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093460 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K093460 24 fields · synced Oct 1, 2026