Identifiers
- 510(k) Number
- K180693 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 quantitative measurement of prothrombin time (PT) in capillary blood or non-anticoagulated venous whole blood. It falls under the category of coagulation test systems, specifically for monitoring anticoagulation therapy. The device provides rapid and accurate results, enabling healthcare professionals to assess coagulation status in patients on oral anticoagulants, such as warfarin.
This system is supplied as a combination of a handheld meter and disposable test strips, intended for single-use per test. It operates outside controlled laboratory settings, offering flexibility for use in clinics, physician offices, or home healthcare environments. The device adheres to regulatory standards, including FDA 510(k) clearance under the Hematology advisory committee, and is classified as a Class II medical device under regulation 864.7750. No sterility or MRI safety considerations are specified for the device components.
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 helps healthcare professionals assess coagulation status in patients on oral anticoagulants, such as warfarin, enabling timely adjustments to therapy.
How is the CoaguChek XS Pro System supplied, and is it single-use?
The system is supplied as a combination of a handheld meter and disposable test strips. Each test strip is intended for single-use only, ensuring accuracy and hygiene for each measurement.
Where can the CoaguChek XS Pro System be used, and what environments are suitable?
This device is intended for use outside controlled laboratory settings, making it flexible for clinics, physician offices, or home healthcare environments. Its portability and ease of use allow for point-of-care testing.
Are there any sterility or MRI safety considerations for the CoaguChek XS Pro System?
The device components do not specify any sterility requirements or MRI safety considerations. The handheld meter and disposable test strips are designed for non-sterile, point-of-care use without exposure to MRI environments.
What regulatory status does the CoaguChek XS Pro System hold?
The CoaguChek XS Pro System holds FDA 510(k) clearance under the Hematology advisory committee and is classified as a Class II medical device under regulation 864.7750. This clearance indicates it is deemed substantially equivalent to a predicate 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. Sources consulted: CoaguChek® XS Pro system - Roche Diagnostics USA, CoaguChek® XS system - Roche Diagnostics USA, ROCHE COAGUCHEK XS SYSTEM USER MANUAL Pdf Download, 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 | K180693 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K180693 24 fields · synced Oct 1, 2026