(256 days)
Not Found
No
The summary describes a chemical reagent for a laboratory test and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The T-Tek Thrombin Time Reagent is an in vitro diagnostic device used for the quantitative determination of thrombin time to detect disorders of fibrinogen; it does not treat or prevent disease.
Yes
This device is used to detect disorders of fibrinogen, which is a diagnostic purpose.
No
The device is a reagent, which is a chemical substance used in a chemical reaction to detect, measure, examine, or produce other substances. It is a physical component used in a laboratory test, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of thrombin time in citrated plasma." This is a test performed on a sample taken from the human body (plasma) to provide information about a physiological state (fibrinogen disorders).
- Device Description: The description reinforces that it's a reagent used for a "quantitative clotting test performed on citrated human plasma samples."
- Purpose: The test is used to "detect disorders of fibrinogen," which is a diagnostic purpose.
- Setting: It's intended for use in an "appropriate clinical laboratory by qualified laboratory professionals," which is a typical setting for IVD testing.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.
Product codes (comma separated list FDA assigned to the subject device)
GJA
Device Description
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma.
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
an appropriate clinical laboratory by qualified laboratory 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)
In correlation studies normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy, were tested using both reagents. Comparison of data from thrombin time testing at two sites and on two different instrument types yielded correlation coefficients of r2 = 0.801 (photo-optical), slope = 0.848, intercept = 3.466 and 2 = 0.800 (mechanical), slope = 1.204, intercept = - 4.904. Within-run and between-run precision studies were also performed and CV's of less than 3% were obtained for the proposed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficients of r2 = 0.801 (photo-optical), slope = 0.848, intercept = 3.466 and 2 = 0.800 (mechanical), slope = 1.204, intercept = - 4.904.
CV's of less than 3%
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.
STA Thrombin, K884384
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
§ 864.7875 Thrombin time test.
(a)
Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.(b)
Classification. Class II (performance standards).
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Premarket Notification 510(k) T-Tek
DEC 1 2 2005
8.0 Premarket Notification 510(k) Summary [As required by section 807.92(c)]
| Applicant: | Michael J. Morris
R2 Diagnostics, Inc.
412 South Lafayette Blvd.
South Bend, IN 46601
USA |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Peggy S. Carter
R2 Diagnostics, Inc.
412 South Lafayette Blvd.
South Bend, IN 46601
TEL: (574) 288-4377
FAX: (574) 288-2272 |
| Date: | October 25, 2005 |
| Trade Name: | R2 Diagnostics T-Tek |
| Common Name: | Thrombin time test |
| Classification Name: | Test, thrombin time
(per 21 CFR section 864.7875) |
| Comparison Device: | STA Thrombin, K884384 |
Description of the Device and Intended Use
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.
1
Summary of Substantial Equivalence Comparisons
R2 Diagnostics T-Tek Thrombin Time Reagent is substantially equivalent in intended use and performance to STA Thrombin 10. Both the predicate device and the proposed product are formulated to determine thrombin time in citrated plasma. In correlation studies normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy, were tested using both reagents. Comparison of data from thrombin time testing at two sites and on two different instrument types yielded correlation coefficients of r2 = 0.801 (photo-optical), slope = 0.848, intercept = 3.466 and 2 = 0.800 (mechanical), slope = 1.204, intercept = - 4.904. Within-run and between-run precision studies were also performed and CV's of less than 3% were obtained for the proposed device. CV's of less than 3% are reported for the predicate device in the manufacturers Instructions for Use.
Conclusion: Substantial Equivalence Statement
In Summary, the similar intended use, technological characteristics and the performance data provided in this premarket notification demonstrate that R2 T-Tek Thrombin Time Reagent is substantially equivalent to (Diagnostica Stago) American Bioproducts Co., STA Thrombin 10.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 2 2005
Dr. Peggy S. Carter Director, Product Development R2 Diagnostics, Inc. 412 South Lafayette Blvd South Bend, IN 46601
K050817 Re: Trade/Device Name: T-Tek Regulation Number: 21 CFR 864.7875 Regulation Name: Thrombin time test Regulatory Class: Class II Product Code: GJA Dated: October 26, 2005 Received: November 1, 2004
Dear Dr. Carter:
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 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.
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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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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6.0 Indications for Use
510(k) Number (if known): _KOSOKIT
Device Name: ____T-Tek
Indications for Use:
Statement of Indications for Use
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
Prescription Use X (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 Device Evaluation (ODE)
Page _1_of _1
(Posted November 13, 2003)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050817