(224 days)
Not Found
No
The description details a mechanical method of detecting coagulation based on the movement of iron particles, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a quantitative prothrombin time (PT) testing strip used for monitoring warfarin therapy. It is not designed to directly treat or alleviate a medical condition, but rather to provide diagnostic information.
Yes
Explanation: The device is intended for "quantitative prothrombin time (PT) testing for monitoring of warfarin therapy," which is a diagnostic measurement used to assess a patient's coagulation status and guide treatment adjustments.
No
The device description clearly outlines a physical test strip with reagents and iron particles, used in conjunction with a monitor, indicating it is a hardware-based medical device, not software-only.
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 reagents to measure coagulation. This process of analyzing a biological sample to obtain a diagnostic result is characteristic of an IVD.
- Sample Type: The device uses "fresh capillary or non-anticoagulated venous whole blood," which are biological specimens.
- Purpose: The purpose is to "accurately measure blood PT values," which are used for diagnostic and monitoring purposes in healthcare.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
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 S System by professional health care providers.
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.
The CoaguChek S System is intended for quantitative Prothombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers.
Product codes (comma separated list FDA assigned to the subject device)
GJS, JPA
Device Description
The PT•S test strip, used as directed with the CoaguChek S 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. The PT-S test strip and controls are similar to the ITC ProTime System in the following items: Test Principle - Measures the PT using fibrin clot formation and detection. Reagents - Sensitive recombinant thromboplastin with an ISI of approximately 1.0.
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.
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)
Normal Range: When the PT•S test was performed using the CoaguChek S 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: The CoaguChek S System has a PT reportable range of 0.8 - 6.0 INR.
Factor Sensitivity: Internal studies were performed utilizing four replicates of each Factor Level (II, V, VII and X). Samples were assayed on the CoaguChek S and Ortho Recombiplastin on the MLA 900 Analyzer. Results are shown as graphs in the test strip insert.
Hematocrit Range: Hematocrit ranges between 32-52% do not significantly affect test results.
Heparin Levels: 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.
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 S monitors.
Level 1 Mean INR 1.2, SD %CV: Lot to Lot 0.03 2.49, Monitor to monitor 0.01 0.61, Strip to strip 0.05 3.79, Total 0.06 4.57.
Level 2 Mean INR 3.0, SD %CV: Lot to Lot 0.07 2.35, Monitor to monitor 0.03 1.17, Strip to strip 0.15 5.13, Total 0.17 5.76.
Precision with blood: Whole blood precision for venous samples was determined from sample duplicates at three external sites. Whole blood capillary data was collected from sample duplicates at two external sites. Bland Altman plots for both capillary and venous blood are provided in the test strip insert.
Accuracy:
Venous: 506 venous samples were collected from 255 outpatients at three 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.
Results: y = 1.049x - 0.08, Slp Cl (1.028, 1.070), Int Cl (-0.13, -0.03), Correlation = 0.975.
Capillary: 294 capillary samples were collected from 147 outpatients at two external sites. Capillary blood samples were assayed on the CoaguChek S 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.
Results: y = 1.048x - 0.10, Slp Cl (1.017, 1.079), Int Cl (-0.17, -0.02), Correlation = 0.969.
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.
International Technidyne Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette (K010599)
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 | |
|---|---|
| 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 22, 2002 | |
| 2) Device name | Proprietary name: PT•S Test Strips and Controls for the CoaguChek S 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 |
OCT 2 4 2002
.
1020831/
1
510(k) Summary Continued
The PT•S test strip is intended for quantitative prothrombin time (PT) testing 4) Device for monitoring of warfarin therapy, using fresh capillary or non-Description anticoagulated venous whole blood with the CoaguChek S 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 Cournadin®, 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 S 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 (PT) testing for monitoring of warfarin 5) Intended use therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers.
The Roche Diagnostics PT.S test strip and controls for the CoaguChek S 6) Comparison to predicate System are substantially equivalent to other products in commercial device distribution intended for similar use. Most notably, the PT.S test strip and substantially equivalent to International Technidyne controls are Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette (K010599).
2
510(k) Summary Continued
| 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 S 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 S System |
| Normal Range | Not Indicated in the ProTime Insert. | When the PT•S test was performed
using the CoaguChek S 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 S System has a PT
reportable range of 0.8 - 6.0 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 S 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. |
The key difference between the PT-S test strip and the ProTime Differences from predicate Microcoagulation System is the location of the Quality Controls. Both 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 PT.S test strip utilizes external liquid controls.
3
510(k) Summary, Continued
The following chart shows a comparison of performance characteristics for the Performance PT.S test strip and the ProTime Microcoagulation System. characteristics
4
510(k) Summary, Continued
| Claim | ProTime Microcoagulation System (K010599)
As Indicated in the ProTime Device Insert | PT-S Test Strips For Use With CoaguChek S System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Precision with controls | Precision testing was conducted with two levels of standard control plasma substrate preparations.
Standard ProTime cuvette:
N mean SD Level I within day 17 0.9 0.06 day to day 4/day 1.0 0.08 Level III within day 19 3.2 0.19 day to day 4/day 3.2 0.12 ProTime 3 cuvette: N mean SD Level I within day 18 0.9 0.07 day to day 4/day 0.9 0.12 Level III within day 20 4.0 0.19 day to day 4/day 4.2 0.22 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 S monitors. The following data was obtained:
Level 1 Mean INR 1.2
SD %CV Lot to Lot 0.03 2.49 Monitor to monitor 0.01 0.61 Strip to strip 0.05 3.79 Total 0.06 4.57 Level 2 Mean INR 3.0
SD %CV Lot to Lot 0.07 2.35 Monitor to monitor 0.03 1.17 Strip to strip 0.15 5.13 Total 0.17 5.76 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Precision with blood | Not Indicated in the ProTime Insert. | Whole blood precision for venous samples was determined from sample duplicates at three external sites. Whole blood capillary data was collected from sample duplicates at two external sites.
Bland Altman plots for both capillary and venous blood are provided in the test strip insert | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
5
510(k) Summary, Continued
| Claim | | ProTime Microcoagulation System
(K010599)
As Indicated in the ProTime Device Insert | PT•S Test Strips For Use With
CoaguChek S 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.
Standard ProTime cuvette vs Lab (Plasma) | 506 venous samples were collected
from 255 outpatients at three 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: |
| | | Regression equation | |
| | Fingerstick | y=0.94x + 0.38 | |
| | Venous | y=0.91x + 0.44 | |
| | | r | y = 1.049x - 0.08 |
| | | 0.95 | Slp Cl (1.028, 1.070) |
| | | 0.94 | Int Cl (-0.13, -0.03) |
| | | n | Correlation = 0.975 |
| | | 229 | |
| | | 232 | |
| | | ProTime 3 cuvette vs Lab (Plasma): | 294 capillary samples were collected
from 147 outpatients at two external
sites. Capillary blood samples were
assayed on the CoaguChek S 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: |
| | | Regression equation | |
| | Fingerstick | y=1.05x + 0.07 | |
| | Venous | y=0.97x + 0.19 | |
| | | r | y = 1.048x - 0.10 |
| | | 0.95 | Slp Cl (1.017, 1.079) |
| | | 0.95 | Int Cl (-0.17, -0.02) |
| | | n | Correlation = 0.969 |
| | | 229 | |
| | | 219 | |
.
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SOT 2 4 2002
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K020831
Trade/Device Name: PT.S Test Strips and Controls for the CoaguChek™ S System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS, JPA Dated: July 22, 2002 Received: July 23, 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 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 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 mav 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 (QS) 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 Sutman
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
510(k) Number (if known): K020831
Device Name: PT.S Test Strips and Controls for the CoaguChek™ S System
Indications for Use:
The CoaguChek S System is intended for quantitative Prothombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers. :
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auchin Bautister
Divis n of Clinical Laboratory Device
510(k) Number K020831
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
4