(193 days)
Not Found
No
The device description details a mechanical process of detecting blood coagulation using magnetic fields and iron particles, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is used for monitoring drug therapy (warfarin) by providing diagnostic information (PT testing), not for directly treating a disease or condition.
Yes
The device is described as "intended for quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy," which is a diagnostic activity used to assess a patient's condition for treatment.
No
The device description explicitly mentions a "CoaguChek monitor" and "PT•S test strip," which are physical hardware components used in conjunction with the software to perform the PT testing. The description details the physical process of blood being drawn into a reaction chamber on the test strip and the monitor displaying the result, indicating a hardware-dependent system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood". This describes a test performed on a biological sample (blood) outside of the body to provide information about a patient's health status (monitoring warfarin therapy).
- Device Description: The description details how the test strip interacts with the blood sample and uses reagents to measure coagulation time. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance studies evaluating precision and accuracy with blood samples further supports its classification as an IVD, as these studies are required for devices that perform diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
For quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers.
The CoaguChek System is intended for quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional healthcare providers.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The PT•S test strip is intended for quantitative prothrombin time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood with the CoaguChek System by professional health care providers.
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
professional health care providers. 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision with controls: The monitor-to-monitor, lot-to-lot and strip-to-strip variability was assessed during internal studies which used two levels of liquid controls, with three test strip lots across nine CoaguChek monitors.
Level 1: Mean INR 1.3, SD Lot to Lot 0.02, Monitor to monitor 0.01, Strip to strip 0.04, Total 0.05. %CV Lot to Lot 1.72, Monitor to monitor 0.95, Strip to strip 3.32, Total 3.86.
Level 2: Mean INR 3.4, SD Lot to Lot 0.05, Monitor to monitor 0.08, Strip to strip 0.13, Total 0.16. %CV Lot to Lot 1.33, Monitor to monitor 2.22, Strip to strip 3.79, Total 4.59.
Precision with blood: Whole blood precision for venous samples was determined from sample duplicates at four external sites. Whole blood capillary data was collected from sample duplicates at three external sites. Bland Altman plots for both capillary and venous blood are provided in the test strip insert.
Accuracy: 610 venous samples were collected from 309 outpatients at four external sites. The INR of each sample was compared to the INR of a venous plasma sample measured on an MLA 900 Analyzer, using Ortho Recombiplastin. A scatterplot graph is provided in the test strip insert. The results are as follows: y = 1.065x - 0.12, Slp Cl (1.041, 1.090), Int Cl (-0.19, -0.06), Correlation = 0.961.
448 capillary samples were collected from 226 outpatients at three external sites. Capillary blood samples were assayed on the CoaguChek monitor with the PT•S test strips and venous plasma samples were measured on an MLA 900 analyzer with Ortho Recombiplastin. A scatterplot graph is provided in the test strip insert. The results are as follows: y=1.089x - 0.17, Slp Cl (1.058, 1.119), Int Cl (-0.25, -0.09), Correlation = 0.958.
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
| 510(k) Summary | OCT 25 2002 |
|---|---|
| ---------------- | ------------- |
| 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: October 21, 2002 |
| 2) Device name | Proprietary name: PT•S Test Strips and Controls for the CoaguChek System Common name: Prothrombin time test Classification name: Prothrombin time test |
| 3) Predicate device | We claim substantial equivalence to International Technidyne Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette (K010599) |
Continued on next page
:
1
| 4) Device
Description | The PT•S test strip is intended for quantitative prothrombin time (PT) testing
for monitoring of warfarin therapy, using fresh capillary or non-
anticoagulated venous whole blood with the CoaguChek System by
professional health care providers. | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. | |
| 5) Intended use | For quantitative Prothrombin Time (PT) testing for monitoring of warfarin
therapy, using fresh capillary or non-anticoagulated venous whole blood by
professional health care providers. | |
| 6) Comparison
to predicate
device | The Roche Diagnostics PT•S test strip and controls for the CoaguChek
System are substantially equivalent to other products in commercial
distribution intended for similar use. Most notably, the PT•S test strip and
controls are substantially equivalent to International Technidyne
Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette
(K010599). | |
| | Continued on next page | |
| Similarities to
predicate
device | The PT•S test strip and controls are similar to the ITC ProTime System in the
following items: | |
| Topic | ProTime Microcoagulation System
(K010599)
As Indicated in the ProTime Device Insert | PT•S Test Strips For Use With
CoaguChek System |
| Intended Use | For the quantitative determination of
prothrombin time from fingerstick whole
blood or anticoagulant-free venous whole
blood. Intended for professional use in
the management of patients treated with
oral anticoagulants. | For the quantitative prothrombin
time (PT) testing for monitoring of
warfarin therapy, using fresh
capillary or non-anticoagulated
venous whole blood by professional
health care providers. |
| Test Principle | Measures the PT using fibrin clot
formation and detection. | Same |
| Reagents | Sensitive recombinant thromboplastin
with an ISI of approximately 1.0. | Same |
| Claim | ProTime Microcoagulation System
(K010599)
As Indicated in the ProTime Device Insert | PT•S Test Strips For Use With
CoaguChek System |
| Normal Range | Not Indicated in the ProTime Insert. | When the PT•S test was performed
using the CoaguChek monitor on 122
normal, healthy, warfarin-free
individuals using venous and capillary
samples, 99% of the venous and
capillary INRs ranged from 0.8 to 1.1. |
| Reportable Range | INR range of 0.8 to 7.0 with a calculated INR
from 0.8 to 9.9. If INR >7.0, the numerical
result is marked with an "*". If INR >9.9 a
message indicating this is displayed.
NOTE: The ProTime gives a numerical
result up to 9.9 INR. | The CoaguChek System has a PT
reportable range of 0.8 - 8.0 INR. |
| Factor Sensitivity | ProTime is sensitive to deficiencies in vitamin
K-dependent coagulation factors known to
influence the PT test (ie. Factors II, VII and X) | Internal studies were performed
utilizing four replicates of each Factor
Level (II, V, VII and X). Samples
were assayed on the CoaguChek and
Ortho Recombiplastin on the MLA
900 Analyzer. Results are shown as
graphs in the test strip insert. |
| Hematocrit Range | Hematocrit levels between 20% and 60% do
not significantly affect test results. | Hematocrit ranges between 32-52%
do not significantly affect test results. |
| Heparin Levels | Results may be affected in patients receiving
heparin or who have an abnormal response to
heparin. | The results are unaffected by heparin
concentrations up to 2.0 U/mL. The
PT•S test strip is insensitive to low
molecular weight heparins up to 1 IU
anti-factor Xa activity/mL. |
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2
Differences The key difference between the PT.S test strip and the ProTime Microcoagulation System is the location of the Quality Controls. Both from predicate device systems offer quality controls that satisfy the same function and requirements. However, the ProTime System utilizes quality controls which are built into the reagent cuvette, where the Roche Diagnostics PT.S test strip utilizes external liquid controls.
Continued on next page
3
Performance characteristics
The following chart shows a comparison of performance characteristics for the PT.S test strip and the ProTime Microcoagulation System.
Continued on next page
4
| Claim | ProTime Microcoagulation System
(K010599)
As Indicated in the ProTime Device Insert | | | PT•S Test Strips For Use With
CoaguChek System | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------|---------------------------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--|
| Precision with
controls | Precision testing was conducted with two levels of
standard control plasma substrate preparations. | | | The monitor-to-monitor, lot-to-lot and
strip-to-strip variability was assessed
during internal studies which used two
levels of liquid controls, with three test
strip lots across nine CoaguChek
monitors. The following data was
obtained: | | | | | |
| | | Standard ProTime cuvette: | N | mean | SD | | | | |
| | Level I | within day | 17 | 0.9 | 0.06 | Level 1 | | | |
| | | day to day | 4/day | 1.0 | 0.08 | | | | |
| | Level III | within day | 19 | 3.2 | 0.19 | | Mean INR 1.3 | | |
| | | day to day | 4/day | 3.2 | 0.12 | | SD | %CV | |
| | | ProTime 3 cuvette: | N | mean | SD | Lot to Lot
Monitor to monitor
Strip to strip
Total | 0.02
0.01
0.04
0.05 | 1.72
0.95
3.32
3.86 | |
| | Level I | within day | 18 | 0.9 | 0.07 | Level 2 | | | |
| | | day to day | 4/day | 0.9 | 0.12 | | | | |
| | | | | | | Mean INR 3.4 | | | |
| | | | | | | | SD | %CV | |
| | Level III | within day | 20 | 4.0 | 0.19 | Lot to Lot | 0.05 | 1.33 | |
| | | day to day | 4/day | 4.2 | 0.22 | Monitor to monitor
Strip to strip
Total | 0.08
0.13
0.16 | 2.22
3.79
4.59 | |
| Precision with
blood | Not Indicated in the ProTime Insert. | | | | | | Whole blood precision for venous
samples was determined from sample
duplicates at four external sites.
Whole blood capillary data was
collected from sample duplicates at
three external sites.
Bland Altman plots for both capillary
and venous blood are provided in the
test strip insert. | | |
Continued on next page
5
| Claim | ProTime Microcoagulation System
(K010599)
As Indicated in the ProTime Device Insert | | PT•S Test Strips For Use With
CoaguChek System | |
|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Accuracy | INR results generated by the ProTime and
ProTime 3 cuvettes using venous and fingerstick
whole blood samples were compared to INR
values obtained using standard Laboratory Plasma
PT Methods with samples collected in 3.2%
sodium citrate tubes. The following accuracy data
were obtained. | | 610 venous samples were collected
from 309 outpatients at four external
sites. The INR of each sample was
compared to the INR of a venous
plasma sample measured on an MLA
900 Analyzer, using Ortho
Recombiplastin. A scatterplot graph is
provided in the test strip insert. The
results are as follows:
$y = 1.065x - 0.12$
Slp Cl (1.041, 1.090)
Int Cl (-0.19, -0.06)
Correlation = 0.961 | |
| | Standard ProTime cuvette vs Lab (Plasma):
Regression equation | r | n | |
| | Fingerstick
Venous | $y=0.94x + 0.38$
$y=0.91x + 0.44$ | 0.95
0.94 | 229
232 |
| | ProTime 3 cuvette vs Lab (Plasma):
Regression equation | 448 capillary samples were collected
from 226 outpatients at three external
sites. Capillary blood samples were
assayed on the CoaguChek monitor
with the PT•S test strips and venous
plasma samples were measured on an
MLA 900 analyzer with Ortho
Recombiplastin. A scatterplot graph is
provided in the test strip insert. The
results are as follows: | | |
| | Fingerstick
Venous | $y=1.05x + 0.07$
$y=0.97x + 0.19$ | 0.95
0.95 | 229
219 |
| | | | $y=1.089x - 0.17$
Slp Cl (1.058, 1.119)
Int Cl (-0.25, -0.09)
Correlation = 0.958 | |
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows a circular logo for the Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "HUMAN SERVICES DEPARTMENT" is arranged around the top of the circle.
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
Re: K021190
Trade/Device Name: PT.S Test Strips and Controls for the CoaguChek System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: August 29, 2002 Received: August 30, 2002
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 reguirements 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 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); 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.
7
Page 2
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
22 119 510(k) Number (if known):
.
Device Name: PT.S Test Strips and Controls for the CoaguChek System
Indications for Use:
The CoaguChek System is intended for quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional healthcare providers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Division of Clinical Laboratory Devices
510(k) Number K021190
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)