(66 days)
Not Found
No
The description focuses on a mechanical method of detecting coagulation (movement of iron particles) and does not mention any computational analysis or algorithms that would suggest AI/ML.
No.
The device is for quantitative diagnostic testing, not for providing therapy.
Yes
The device quantitatively measures prothrombin time (PT) in fresh capillary blood to monitor anticoagulant levels, which is a diagnostic function used to assess a patient's condition and guide treatment.
No
The device description explicitly details a physical test strip ("PT.S test strip") that interacts with a "CoaguChek monitor" and uses "tiny iron particles" and "alternating magnetic fields" to measure blood coagulation. This involves significant hardware components and physical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For quantitative prothrombin time testing in fresh capillary blood". This indicates that the device is used to examine specimens derived from the human body (blood) to provide information for diagnostic purposes (monitoring anticoagulant levels).
- Device Description: The description details how the device works by mixing blood with reagents and measuring the time it takes for coagulation to occur. This is a classic example of an in vitro test.
- Testing of Specimens: The device tests "fresh capillary blood," which is a specimen taken from the human body.
Therefore, based on the provided information, the CoaguChek PT.S Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The CoaguChek PT.S Test is for quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor. Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Coumadin®, is a commonly used anticoagulant. Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The PT.S test strip uses a modified version of this method. The PT.S test strip, used as directed with the CoaguChek monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.
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
properly selected and suitably trained patients or their caregivers
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)
Accuracy:
N = 84 observations
Slope = 1.011
Intercept = -0.03
Correlation Coefficient = 0.978
Precision:
Patient Results
N=841
Mean=2.33
SD=0.15
CV=6.45
Professional Results
N=140
Mean=2.35
SD=0.14
CV=5.79
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
K03084/5
510(k) Summary
MAY 22 2003
| 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. | |
| P.O. Box 50457 | |
| Indianapolis, IN 46250-0457 | |
| Contact Person: Jennifer Tribbett | |
| Date Prepared: March 14, 2003 | |
| 2) Device name | Proprietary name: CoaguChek™ PT•S Test for Prothrombin Time Self-Testing |
| Common name: Prothrombin time test | |
| Classification name: Prothrombin time test | |
| 3) Predicate device | The Roche Diagnostics PT•S test strip and controls on the CoaguChek System for Patient Self-Testing are substantially equivalent to other products in commercial distribution intended for Patient Self-Testing. Most notably, the system is substantially equivalent to the currently marketed CoaguChek System for Prothrombin Time Self-Testing (K962571). |
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:
1
510(k) Summary, Continued
The CoaguChek PT.S Test is for quantitative prothrombin time testing in 4) Device Description fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Coumadin®, is a commonly used anticoagulant. Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The PT.S test strip uses a modified version of this method.
The PT.S test strip, used as directed with the CoaguChek monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.
For quantitative prothrombin time testing in fresh capillary blood with the 5) Intended use CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
2
510(k) Summary, Continued
- Similarities to and differences from predicate device
| Topic | CoaguChek System for Prothrombin
Time Self-Testing
(K962571) | CoaguChek System for
Prothrombin Time Self-Testing
with the PT•S Test Strip and
Controls |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For quantitative prothrombin time (PT)
testing in fresh capillary blood with the
CoaguChek System by properly selected
and suitably trained patients or their
caregivers on the prescription or other
order of the treating doctor. | Same |
| Test Principle | After placing a drop of fresh capillary
blood on the test strip, the blood drawn
into the reaction chamber and mixed
with reagents that cause coagulation to
begin. In the test strip, tiny iron particles
are mixed with the sample. Alternating
magnetic fields cause the iron particles
to move within the sample. The test is
complete when the blood clot stops the
iron particles from moving. The PT
result is then displayed by the monitor. | Same |
| Reagents | Each test strip contains rabbit
thromboplastin, stabilizers and
preservatives | Each test strip contains human
recombinant thromboplastin,
stabilizers, a heparin neutralizing
agent and preservatives |
| International
Sensitivity Index | ISI is approximately 2 | ISI is approximately 1 |
| Storage and
Stability | You may store strips at room
temperature for up to 60 days, then
refrigerate until the "Use By" date. | (Improved) You may store strips at
room temperature for up to 90 days,
then refrigerate until the "Use By"
date. |
| Topic | CoaguChek System for Prothrombin
Time Self-Testing
(K962571) | CoaguChek System for
Prothrombin Time Self-Testing
with the PT•S Test Strip and
Controls |
| Storage and
Stability | Remove one test strip foil pouch from
the refrigerator. Allow the sealed pouch
to set at room temperature for at least
five minutes before opening for testing. | (Improved) A warm up period of 5
minutes is not necessary with the
PT•S test strip. |
| Storage and
Stability | Use the test strip within four minutes
after opening the foil pouch. | (Improved) Use the test strip within
ten minutes after opening the foil
pouch |
| Quality Control
Recommendation | Two levels of control should be tested
upon receipt of each test strip carton
and each day of use. | Same |
| Verified Clinical
Range | 0.6 - 8.0 INR | 0.8 - 8.0 INR |
| Accuracy | N = 315 observations
Slope = 0.973
Intercept = 0.05
Correlation Coefficient = 0.966 | N = 84 observations
Slope = 1.011
Intercept = -0.03
Correlation Coefficient = 0.978 |
| Precision | Patient Results
Professional Results | Patient Results
Professional Results |
| | N
1070
Mean
3.81
SD
0.39
CV
10.31 | N
841
Mean
2.33
SD
0.15
CV
6.45 |
| | N
40
Mean
3.78
SD
0.35
CV
9.30 | N
140
Mean
2.35
SD
0.14
CV
5.79 |
Continued on next page
3
New System vs. Predicate System -Continued-
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
MAY 22 2003
Re: K030845
Trade/Device Name: CoaguChek™ PT•S Test for Prothrombin Time Self-Testing Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: March 14, 2003 Received: March 17, 2003
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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); 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 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.
5
Page 2 -
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
K030845 510(k) Number (if known):
CoaguChek™ PT•S Test for Prothrombin Time Self-Testing Device Name:
Indications for Use:
For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quxeline Bautista
(Division Sign-Q Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)