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PT-S Test Strips for CoaguChek System, Model 2032422

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021190

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K021190 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 PT-S Test Strips for the CoaguChek System, Model 2032422, are diagnostic test strips designed for quantitative prothrombin time (PT) measurement. These strips are intended for use with the CoaguChek monitoring system to assess blood clotting time, specifically for monitoring warfarin therapy in patients. By analyzing fresh capillary or non-anticoagulated venous whole blood, the device provides critical data for anticoagulation management in hematology settings.

The strips are supplied as single-use consumables for professional healthcare use, requiring no sterilization beyond manufacturer packaging. They operate by drawing blood into a reaction chamber, mixing it with reagents and iron particles, and applying alternating magnetic fields to detect clot formation. Compatible with the CoaguChek XS system, these strips are regulated under FDA 510(k) clearance (K021190) as Class II medical devices under product code GJS, adhering to hematology-specific standards for prothrombin time testing.

Frequently asked questions

What is the primary use of the PT-S Test Strips for the CoaguChek System, Model 2032422?

These test strips are designed for quantitative prothrombin time (PT) measurement in patients undergoing warfarin therapy. They analyze fresh capillary or non-anticoagulated venous whole blood to provide critical data for anticoagulation management, ensuring accurate monitoring of blood clotting time in hematology settings.

How are the PT-S Test Strips supplied, and are they reusable?

The PT-S Test Strips are supplied as single-use consumables for professional healthcare use. Each strip is intended for one-time use only, eliminating the need for sterilization beyond the manufacturer’s sealed packaging. This ensures consistency and reliability in test results.

Which CoaguChek system is compatible with these test strips?

These PT-S Test Strips are specifically designed for use with the CoaguChek XS monitoring system. Compatibility ensures accurate and reliable PT measurements, enabling precise anticoagulation management for patients.

Do the PT-S Test Strips require any special handling or storage conditions?

The strips are supplied in manufacturer-packaged, sterile form, requiring no additional sterilization. They should be stored according to the manufacturer’s instructions to maintain their integrity and performance. Proper storage conditions help preserve the reagents and ensure accurate test results.

What regulatory pathway does the PT-S Test Strips follow?

The PT-S Test Strips for the CoaguChek System, Model 2032422, are regulated under FDA 510(k) clearance (K021190) as Class II medical devices. This classification aligns with hematology-specific standards for prothrombin time testing, ensuring compliance with rigorous safety and performance requirements.

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-s Test Strips for The Coaguchek System, Model# 2032422, CoaguChek XS PT Test Strip Package Insert - Roche Diagnostics USA, K021190 FDA 510(k) - PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K021190 24 fields · synced Oct 1, 2026