CoaguSense Prothrombin Time/INR Self-Test Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093243 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 CoaguSense Prothrombin Time/INR Self-Test Monitoring System is an in vitro diagnostic device designed for quantitative measurement of prothrombin time (PT) and international normalized ratio (INR). It employs mechanical clot detection to provide accurate results in seconds and INR units, enabling monitoring of anticoagulant therapy.
This system is intended for self-testing and operates using fresh capillary whole blood. Supplied as a point-of-care or at-home device, it is classified as a Class II medical device under FDA regulations (510(k) clearance, K093243). The device is non-sterile and reusable per manufacturer specifications, with no explicit MRI safety labeling in the provided data.
Frequently asked questions
What types of blood samples can be used with the CoaguSense Prothrombin Time/INR Self-Test Monitoring System, and how is it intended to be used?
The CoaguSense system is designed for use with fresh capillary whole blood, making it ideal for point-of-care or at-home monitoring. It is specifically intended for self-testing by patients to measure prothrombin time (PT) and international normalized ratio (INR) in seconds, enabling them to track their anticoagulant therapy independently.
Is the CoaguSense device reusable, and if so, how should it be maintained?
Yes, the CoaguSense Prothrombin Time/INR Self-Test Monitoring System is reusable according to the manufacturer’s specifications. While it is non-sterile, proper cleaning and maintenance as instructed by CoaguSense Inc. will ensure accurate and reliable performance over time. Always follow the provided guidelines to avoid contamination or damage.
How does the CoaguSense device determine INR levels, and what makes its results reliable for self-testing?
The device uses mechanical clot detection to quantify prothrombin time (PT) and convert those results into INR units. This method provides rapid, accurate measurements in seconds, making it suitable for self-testing at home or in clinical settings. The system is designed to deliver consistent results, supporting effective monitoring of anticoagulant therapy.
What regulatory pathway was followed for the FDA clearance of this device, and what medical specialty does it primarily serve?
The CoaguSense Prothrombin Time/INR Self-Test Monitoring System received FDA clearance through a 510(k) Traditional Review process, classified as substantially equivalent under 510(k) K093243. It falls under the Hematology medical specialty, as indicated by its advisory committee designation (HE). This clearance confirms its compliance with FDA standards for Class II medical devices.
Are there any specific storage instructions for the CoaguSense device, or does it require calibration before use?
The provided data does not specify storage instructions or calibration requirements for the CoaguSense device. However, since it is reusable and non-sterile, proper handling and maintenance (as outlined by the manufacturer) are essential. Always refer to the user manual for detailed guidance on storage, cleaning, and operational readiness.
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: PT/INR System For Lab, Clinics, At-Home Testing - Coag-Sense, CoaguSense Coag-Sense Prothrombin Time PT/INR Self-Test ... - ManualsLib, Coag-Sense™ PT2 PT/INR Self-Test Monitoring System, COAGUSENSE COAG-SENSE USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093243 | Class II | Active |
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Manufacturer
- Manufacturer
- CoaguSense Inc.
- FDA Applicant
- Coagusense, Inc.
Sources (1)
- FDA 510(k) K093243 24 fields · synced Sep 19, 2026