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).

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.

AI/ML Overview

This document (K180693) describes a Special 510(k) Premarket Notification for the CoaguChek XS Pro System. The purpose of this submission is not to introduce a new device or change the core functionality of the existing CoaguChek XS Pro System (cleared under K093460). Instead, it's to add Super Sani-Cloth wipes to the approved cleaning and disinfection procedures for the device, replacing 10% sodium hypochlorite solution. Therefore, the acceptance criteria and study described focus on the device's robustness and continued performance after repeated exposure to the new cleaning agent.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No impact on meter accuracy after cleaning and disinfection cycles.	Meter accuracy was not impacted by the cleaning and disinfection procedure involving Super Sani-Cloth wipes.
No impact on meter functionality after cleaning and disinfection cycles.	Meter functionality was not impacted by the cleaning and disinfection procedure involving Super Sani-Cloth wipes.
Device continues to meet performance requirements for its intended use after cleaning and disinfection cycles.	Robustness and effectiveness cleaning and disinfecting testing demonstrated that the device meets the performance requirements for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: "CoaguChek XS Pro meters that had been subjected to 10,950 C&D cycles". This refers to the number of cleaning and disinfection cycles applied to the meters, not individual patient samples. The number of actual meters tested is not explicitly stated in this excerpt, but it implies a sufficient number were used to confirm the robustness over the simulated lifetime.
Data Provenance: Not explicitly stated, but given this is a robustness study for cleaning chemicals, it would likely be laboratory-based testing conducted by the manufacturer (Roche Diagnostics). It is implicitly prospective testing as the devices were subjected to a defined number of cleaning cycles.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This study is not a diagnostic performance study requiring expert interpretation of results to establish ground truth (e.g., radiologists reviewing images). Instead, it focuses on the physical and functional integrity of the device after exposure to cleaning agents. The "ground truth" here is the original, un-degraded performance of the CoaguChek XS Pro System, against which the post-cleaning performance is compared.

4. Adjudication Method for the Test Set

Not applicable. This study does not involve expert adjudication of results. The assessment is based on objective measurements of meter accuracy and functionality compared to established performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This is not an MRMC study. An MRMC study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a study validating a cleaning agent's compatibility with a medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, effectively. The study implicitly evaluates the "standalone" performance of the CoaguChek XS Pro System itself after undergoing the cleaning process. The CoaguChek XS Pro System is a quantitative measurement device, and its accuracy and functionality are assessed intrinsically, not in conjunction with human interpretation in the way an AI diagnostic algorithm would be.

7. The Type of Ground Truth Used

Established Performance Specifications / Reference Method. The "ground truth" is the expected accurate and functional performance of the CoaguChek XS Pro System when measuring prothrombin time using venous blood, against which the performance of the repeatedly cleaned meters is compared. The original clearance (K093460) would have established the accuracy of the device against a reference method.

8. The Sample Size for the Training Set

Not applicable. This is a validation study for cleaning procedures, not a machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is not relevant.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 RoadP.O. Box 50416Indianapolis, IN 46250-0457
Contact	Angie ClementsPhone: (317) 521-7338FAX: (317) 521-2324Email: angie.clements@roche.comBin SunPhone: (317) 521-3107FAX: (317) 521-2324Email: bin.sun.bs2@roche.com
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,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.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).

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.

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
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).(b)
Classification. Class II (performance standards).