(132 days)
Not Found
No
The summary explicitly states that the fundamental scientific technology has not changed and there are no mentions of AI, DNN, or ML. The modifications are limited to incorporating a barcode scanner.
No
The device is for monitoring coagulation values to help manage medication, not for direct treatment of a condition.
Yes
It quantitatively determines prothrombin time, which is used to monitor coagulation values and is indicated for use by healthcare professionals. This measurement provides information for diagnosis and management of conditions.
No
The device description explicitly states it is a "System" consisting of a "meter" and "test strips," which are hardware components. The modification described is the incorporation of an "embedded barcode scanner," also a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "quantitatively determines prothrombin time ('PT'), using capillary blood or whole blood from a vein". This involves testing a biological sample (blood) outside of the body to obtain diagnostic information.
- Device Description: The description confirms it's a "System" that includes a "meter" and "Test strips". This is typical of IVD devices used for analyzing biological samples.
- Performance Studies: The document includes "Accuracy" and "Precision" studies comparing the device's results to a reference, which are standard performance metrics for IVD devices.
- Predicate Device: The predicate device (K071041; CoaguChek XS Plus System) is also an IVD device used for similar coagulation testing.
All of these points strongly indicate that the CoaguChek XS Pro System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek 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).
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The CoaguChek XS Pro System represents a modification of the CoaguChek XS Plus System to incorporate an embedded barcode scanner. The unmodified device was cleared for use under premarket notification K071041.
The intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s) described in this 510(k).
The fundamental scientific technology of this device has not changed as a result of the modification(s) described in this 510(k).
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
healthcare professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Similarities:
Accuracy compared to the reference:
Venous Blood: N=811, Slope= 1.090, Intercept = -0.2, Correlation = 0.974
Capillary Blood: N = 822, Slope = 1.075, Intercept = -0.1, Correlation = 0.972
Whole Blood Precision:
Venous Blood: N = 399, Mean INR = 2.32, SD = 0.046, CV = 2.00
Capillary Blood: N = 399, Mean INR = 2.26, SD = 0.077, CV = 3.39
Control Precision:
Level 1: N = 538, Mean INR = 1.18, SD = 0.04, CV = 3.37
Level 2: N = 535, Mean INR = 2.95, SD = 0.12, CV = 4.10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 1 8 2010
510(k) Summary
Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
Contact Person: Jennifer Tribbett
Date Prepared: March 15, 2010 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: CoaguChek® XS Pro System
Common name: Prothrombin time test
Classification name: Prothrombin time test |
| 3) Predicate device | The CoaguChek XS Pro System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, the CoaguChek XS Pro System is a modification of the previously cleared CoaguChek XS Plus System (K071041). |
| 4) Device Description | The CoaguChek XS Pro System represents a modification of the CoaguChek XS Plus System to incorporate an embedded barcode scanner. The unmodified device was cleared for use under premarket notification K071041.
The intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s) described in this 510(k).
The fundamental scientific technology of this device has not changed as a result of the modification(s) described in this 510(k). |
1
| 5) Intended Use The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek
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). |
|---|
- Similarities The table below indicates the similarities between the CoaguChek XS Plus System and the CoaguChek XS Pro System.
| Topic | CoaguChek XS Plus System
(predicate: unmodified device) | CoaguChek XS Pro System
(modified device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Features | |
| Intended use | Intended for use by professional
healthcare providers for quantitative
prothrombin time testing for the
monitoring of warfarin therapy. | The CoaguChek XS Pro System
(CoaguChek XS Pro meter and
CoguChek 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). |
| Fundamental technology | Electrochemical technology with
amperometric (electric current) detection
of thrombin activity | Same |
| Sample type | Fresh capillary or non-anticoagulated
venous whole blood | Same |
| Test strip | The CoaguChek XS PT Test Strip | Same |
| Onboard control | Built into every strip and recognized by
the meter | Same |
| External quality control | CoaguChek XS PT Controls are available
as optional external controls | Same |
2
| Topic | CoaguChek XS Plus System
(predicate: unmodified device) | CoaguChek XS Pro System
(modified device) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| System Performance Characteristics | | |
| Measuring range | 0.8 – 8.0 INR | Same |
| Hemotocrit range | Hematocrit ranges between 25 – 55%
have no significant effect on test results | Same |
| Bilirubin | Bilirubin up to 30 mg/dL have no
significant effect on test results | Same |
| Triglyceride | Lipemic samples containing up to 500
mg/dL of triglycerides have no
significant effect on test results. | Same |
| Hemolysis | Hemolysis up to 1000 mg/dL have no
significant effect on test results | Same |
| Heparin | Test results are unaffected by heparin
concentrations up to 0.8 U/mL | Same |
| Topic | CoaguChek XS Plus System
(predicate: unmodified device) | CoaguChek XS Pro System
(modified device) |
| System Performance Characteristics | | |
| Low Molecular Weight
Heparin | The CoaguChek XS PT Test is
insensitive to low molecular weight
heparins (LMWH) up to 2IU anti-factor
Xa activity/mL | Same |
| Accuracy compared to
the reference | Venous Blood:
N=811
Slope= 1.090
Intercept = -0.2
Correlation = 0.974
Capillary Blood:
N = 822
Slope = 1.075
Intercept = -0.1
Correlation = 0.972 | Same |
| Whole Blood Precision | Venous Blood:
N = 399
Mean INR = 2.32
SD = 0.046
CV = 2.00
Capillary Blood:
N = 399
Mean INR = 2.26
SD = 0.077
CV = 3.39 | Same |
| Control Precision | Level 1:
N = 538
Mean INR = 1.18
SD = 0.04
CV = 3.37
Level 2:
N = 535
Mean INR = 2.95
SD = 0.12
CV = 4.10 | Same |
| Topic | CoaguChek XS Plus System
(predicate: unmodified device) | CoaguChek XS Pro System
(modified device) |
| Hardware | | |
| Measurement module
(Measurement engine) | Converts raw signals from test strip into
final PT result. | Same
Measurement Module has not been
modified |
| Handheld Basic Module | Provides the power management of the
AC-adapter or rechargeable batteries and
houses all the data management features. | Same
Handheld Basic Module has not
been modified |
| Software | | |
| Code chip function | Code chip information is stored in meter
to identify test strip and liquid control
information. | Same |
·
3
:
・
.
4
The table below indicates the modified features of the CoaguChek XS Pro System. 7) Differences
.
| Topic | CoaguChek XS Plus System
(predicate: unmodified device) | CoaguChek XS Pro System
(modified device) |
|---------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|
| General Features | | |
| Note: The test strip itself has not been modified | | |
| Capillary sample volume | Blood drop must be minimum 10 µl | Blood drop must be minimum 8 µl |
| Code Chip Modifications | | |
| Blood application time | 120 seconds | 180 seconds |
| Operating temperature | 18° - 32 °C | 15° - 32 °C |
| | Hardware | |
| Barcode Scanner | External Barcode Scanner | Integrated Barcode Scanner |
| Display | LED Display | TFT Display |
| Size | 185 x 98 x 42 mm | 231 x 97 x 43 mm |
| Weight | 311 g (without batteries) | 350 g (without batteries) |
| | Software | |
| Memory | 500 INR results, 500 QC results | 1000 INR results, 500 QC results |
| Display | User interface shows images/icons | Upgraded display shows
images/icons and more descriptive
text. |
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Ms. Jennifer Tribbett Regulatory Program Manager 9115 Hague Road Indianapolis, Indiana 46250
Re: K093460
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: February 8, 2010 Received: February 12, 2010
MAR 1 8 2010
:
Dear Ms. Tribbett:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing
6
Page 2 – Ms. Jennifer Tribbett
your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ie m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K093460
CoaguChek XS Pro System Device Name:
Indications For Use:
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek 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).
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR :
Over-The-Counter Use · (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
GENERAL CERTIFICATE OF SECONDARY E
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KC9346.0
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