CoaguChek XS Pro System

K180693 · Roche Diagnostics · GJS · Apr 19, 2018 · Hematology

Device Facts

• Record ID: K180693
• Device Name: CoaguChek XS Pro System
• Applicant: Roche Diagnostics
• Product Code: GJS · Hematology
• Decision Date: Apr 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Indications for Use

The CoaguChek XS Pro System is intended for the quantitative determination of prothrombin time (PT) in fresh capillary whole blood, fresh venous whole blood, and fresh arterial whole blood. The system is intended for use by healthcare professionals for monitoring patients on oral anticoagulation therapy (e.g., warfarin).

Device Story

CoaguChek XS Pro System; point-of-care coagulation monitor. Input: fresh capillary, venous, or arterial whole blood samples applied to test strips. Operation: electrochemical measurement of prothrombin time (PT). Output: PT results displayed to healthcare professionals for anticoagulation therapy management. Modification: update to cleaning/disinfection protocol, replacing 10% sodium hypochlorite solution with Super Sani-Cloth Germicidal Disposable wipes. Device remains unchanged in fundamental scientific technology, intended use, and patient population.

Clinical Evidence

Bench testing only. Robustness study subjected meters to 10,950 cleaning and disinfection cycles (simulating 3 years of use at 10 tests/day). Performance was verified using venous blood samples; results demonstrated no impact on meter accuracy or functionality compared to baseline.

Technological Characteristics

Point-of-care prothrombin time monitoring system. No changes to fundamental scientific technology, materials, or design from K093460. Device housing and components validated for compatibility with Super Sani-Cloth (quaternary ammonium/alcohol-based) disinfectant wipes.

Indications for Use

Indicated for healthcare professionals to quantitatively determine prothrombin time (PT) in patients taking oral anticoagulation medication (vitamin K antagonists) using capillary or non-anticoagulated venous whole blood.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• CoaguChek XS Pro System (K093460)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION MEMORANDUM

510(k) Number: K180693

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device. CoaguChek XS Pro System; K093460
2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was to replace the previous cleaning and disinfection solution (10% sodium hypochlorite solution) with the Super Sani-Cloth Germicidal Disposable wipes in the product labeling.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

Sponsor followed ISO 14971 Second edition (Medical devices - Application of risk management to medical devices) to evaluate risk specific to cleaning and disinfection of the CoaguChek XS Pro System. The scope of the risk analysis covers disinfectant seeping into the device which may affect heater of the device, battery contact, temperature sensors and strip sensors. It was concluded that the proposed change does not pose any additional risks and there is no impact on the safety or effectiveness of the product.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.