(35 days)
Not Found
No
The submission explicitly states that no technological changes have been made to the device since its previous clearance, and the focus is solely on the cleaning and disinfection procedure. There is no mention of AI or ML in the description or performance studies.
No
The device is described as a system for "quantitative prothrombin time testing for the monitoring of warfarin therapy," which indicates a diagnostic rather than a therapeutic function.
Yes
The device is intended for quantitative prothrombin time testing to monitor warfarin therapy, which is a diagnostic function to assess a patient's coagulation status. The submission also refers to the device's accuracy and functionality in the context of its performance.
No
The device description explicitly states that this submission deals only with the performance of cleaning and disinfection wipes for the existing CoaguChek XS Plus System, which is a hardware device for prothrombin time testing.
Yes, based on the provided information, the CoaguChek XS Plus system is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative prothrombin time testing for the monitoring of warfarin therapy." This is a diagnostic test performed on a biological sample (blood) outside of the body.
- Sample Type: It uses "fresh capillary or non-anticoagulated venous whole blood," which are biological specimens.
- Purpose: The purpose is to provide quantitative results (prothrombin time) to aid in monitoring a medical condition (warfarin therapy).
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoaguChek XS Plus system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
Product codes
GJS
Device Description
No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041. Thus, the device description for the CoaguChek XS Plus System remains the same as that presented and cleared in K071041.
This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Plus System housing and components.
Please note that we intend to modify the CoaguChek XS Plus System labeling by adding 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Robustness and effectiveness cleaning and disinfecting testing on the CoaguChek XS Plus 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 Plus 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2018
Roche Diagnostics Bin Sun Regulatory Affairs Principal 9115 Hague Road Indianapolis, Indiana 46250
Re: K180684
Trade/Device Name: CoaguChek XS Plus System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS Dated: March 14, 2018 Received: March 15, 2018
Dear Bin Sun:
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
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 mediation-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) K180684
Device Name CoaguChek® XS Plus System
Indications for Use (Describe)
The CoaguChek XS Plus system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
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 Plus 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 Plus Super Sani Cloth claims extension. The CoaguChek XS Plus 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 Plus 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 Plus System has not changed since its clearance on K071041. No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041. This submission pertains only to the performance of Super Sani- Cloth wipes for the effective cleaning and disinfecting of the CoaguChek XS Plus System housing and components.
Please note that we intend to add the Super Sani-Cloth to the CoaguChek XS Plus 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 |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Bin Sun |
| Phone: (317) 521-3107 | |
| FAX: (317) 521-2324 | |
| Email: bin.sun.bs2@roche.com |
Angie Clements
Phone: (317) 521-7338
FAX: (317) 521-2324
Email: angie.clements@roche.com |
| Date Prepared | March 9, 2018 |
| Proprietary Name | CoaguChek XS Plus System |
| Common Name | Test, Time, Prothrombin |
| Classification Name | Prothrombin time test |
| Product Codes,
Regulation Numbers | GJS, Class II, 21 CFR 864.7750 |
| Predicate Devices | The 510(k) history for the CoaguChek XS Plus System is K071041, cleared on May 11, 2007.
Please note that in this submission we did not make any changes or enhancements to the CoaguChek XS Plus system. |
| Establishment Registration | For the CoaguChek XS Plus System, the establishment registration number for Roche
Diagnostics GmbH in Mannheim, Germany is 9610126. |
5
1. DEVICE DESCRIPTION
No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041.
Thus, the device description for the CoaguChek XS Plus System remains the same as that presented and cleared in K071041.
This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Plus System housing and components.
Please note that we intend to modify the CoaguChek XS Plus System labeling by adding 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 Plus 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 Plus System remains the same as the cleared CoaguChek XS Plus System (K071041).
The CoaguChek XS Plus system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
TECHNOLOGICAL CHARACTERISTICS 3.
The fundamental scientific technology of the CoaguChek XS Plus System (K071041) has not changed.
ACCESSORY NAME (SUPER SANI-CLOTH) 4.
Proprietary name: Super Sani-Cloth (manufactured by PDI)
6
Classification names: Disinfectant, Medical Devices
Subsequent Product Code: LRJ, General Purpose Disinfectant
510(k) History: n/a, Class I exempt
INSTRUMENT CLEANING AND DISINFECTION ROBUSTNESS STUDY 5.
No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041.
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 Plus 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 Plus 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 Plus 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 Plus 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.
UPDATED LABELING 6.
The CoaguChek XS Plus Operator's Manual has been updated to reflect Super Sani-Cloth. This is included in Section 10. The Maintenance & Care topic starts on page 121.