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

Intended 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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April 19, 2018

Roche Diagnostics Angie Clements Regulatory Affairs Principal 9115 Hague Road Indianapolis, Indiana 46250

Re: K180693

Trade/Device Name: CoaguChek XS Pro System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS Dated: March 19, 2018 Received: March 20, 2018

Dear Angie Clements:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Leonthena R. Carrington -S

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180693

Device Name CoaguChek® XS Pro System

### Indications for Use (Describe)

The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# CoaguChek XS Pro Super Sani Cloth claims extension

# Special 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

In accordance with 21 CFR 807.87. Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).

The purpose of this Special 510(k) Premarket Notification is to obtain FDA review and clearance for the CoaguChek XS Pro Super Sani Cloth claims extension. The CoaguChek XS Pro System labeling will be modified to add a new cleaning and disinfecting product for use with our device, Super Sani-Cloth® (EPA #9480-4).

The CoaguChek XS Pro System is a prothrombin time test system, a Class II medical device according to 21 CFR 864.7750. Super Sani-Cloth is a General Purpose Disinfectant, a Class I exempt product, according to 21 CFR 880.6890.

The CoaguChek XS Pro System has not changed since its clearance on K093460. No technological. material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460. This submission pertains only to the performance of Super Sani- Cloth wipes for the effective cleaning and disinfecting of the CoaguChek XS Pro System housing and components.

Please note that we intend to add the Super Sani-Cloth to the CoaguChek XS Pro System product labeling for cleaning and disinfection purposes. Previously, 70% ethanol or isopropyl alcohol and 10% sodium hypochlorite solution were cleared as recommended cleaning/disinfecting solutions. The Super Sani-Cloth will replace the sodium hypochlorite solutions in the product labeling.

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| Submitter Name | Roche Diagnostics |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 9115 Hague Road<br>P.O. Box 50416<br>Indianapolis, IN 46250-0457 |
| Contact | Angie Clements<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail]<br><br>Bin Sun<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | March 15, 2018 |
| Proprietary Name | CoaguChek XS Pro System |
| Common Name | Prothrombin time test |
| Classification Name | Prothrombin time test, 21 CFR 864.7750 |
| Product Codes,<br>Regulation Numbers | Prothrombin time test, GJS, Class II, 21 CFR 864.7750 |
| Predicate Devices | The 510(k) history for the CoaguChek XS Pro System is K093460, cleared on March 18, 2010.<br>Please note that in this submission we did not make any changes or enhancements to the CoaguChek XS Pro system. |
| Establishment Registration | For the CoaguChek XS Pro System, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The establishment registration number for Roche Diagnostics in Indianapolis, the United States is 1823260 |

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#### 1. DEVICE DESCRIPTION

No technological, material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460.

Thus, the device description for the CoaguChek XS Pro System remains the same as that presented and cleared in K093460.

This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Pro System housing and components.

Please note that we intend to modify the CoaguChek XS Pro System labeling the Super Sani-Cloth for cleaning and disinfection of the system. Previously, 70% ethanol or isopropyl alcohol and 10% sodium hypochlorite solution were cleared as recommended cleaning/disinfecting solutions. The Super Sani-Cloth will replace the sodium hypochlorite solutions in the product labeling.

#### 2. INDICATIONS FOR USE

The use of Super-Sani Cloth wipes for the cleaning and disinfection of the CoaguChek XS Pro System is the focus of this Special 510(k) and does not change the Intended Use or Indications for Use of the system.

Therefore, the Intended Use and Indications for Use for the CoaguChek XS Pro System remains the same as the cleared CoaguChek XS Pro System (K093460).

The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

### TECHNOLOGICAL CHARACTERISTICS 3.

The fundamental scientific technology of the CoaguChek XS Pro System (K093460) has not changed.

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### ACCESSORY NAME (SUPER SANI-CLOTH) 4.

Proprietary name: Super Sani-Cloth (manufactured by PDI)

Classification names: Disinfectant, Medical Devices

Subsequent Product Code: LRJ, General Purpose Disinfectant

510(k) History: n/a. Class I exempt

### 5. INSTRUMENT CLEANING AND DISINFECTION ROBUSTNESS STUDY

No technological, material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460.

The corresponding test results on the device components demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device.

Robustness and effectiveness cleaning and disinfecting testing on the CoaguChek XS Pro System for Super Sani-Cloths demonstrated that the device meets the performance requirements for its intended use. Acceptance criteria were met when testing with venous blood the CoaguChek XS Pro meters that had been subjected to 10,950 C&D cycles representing three-years lifetime of the meter based on a testing frequency of 10 tests per day. Neither meter accuracy nor meter functionality were impacted by the cleaning and disinfection procedure.

Overall, the data demonstrate that the CoaguChek XS Pro System operates in the same manner when cleaning and disinfecting occurs with the Super Sani-Cloth wipes.

Please note that we intend to modify the CoaguChek XS Pro System labeling the Super Sani-Cloth for cleaning and disinfection of the system. Previously, 70% ethanol or isopropyl alcohol and 10% sodium hypochlorite solution were cleared as recommended cleaning/disinfecting solutions. The Super Sani-Cloth will replace the sodium hypochlorite solutions in the product labeling.