(86 days)
Thrombelastograph® Coagulation Analyzer (TEG®) 5000 Series, Chrono-log Corp. Optical Aggregation Systems and Reagents
Not Found
No
The summary describes a laboratory assay and analyzer that measures platelet function using chemical agonists and mechanical analysis. There is no mention of AI, ML, or any computational analysis beyond standard data processing.
No.
The device is an assay intended to assess platelet function, not to treat or prevent a disease.
Yes
The device is described as an "Assay" intended to "assess platelet function" and "measure the inhibition of platelet function" in patients who have received certain drugs, and its performance studies confirm it "reliably detects a reduction in platelet function." Measuring and assessing a biological function or state to provide information about a patient's condition falls under the definition of diagnostics.
No
The device description explicitly states it consists of "a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF," which are physical components, not software. It is an assay used with a hardware analyzer (TEG Hemostasis Analyzer), not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assay is used to "assess platelet function in patients who have received platelet inhibiting drugs." This assessment is performed on a biological sample (blood) taken from the patient.
- Device Description: The device description mentions "a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF, which when used on a heparinized blood sample can measure the inhibition of platelet function." This confirms that the device interacts with a biological sample (blood) in vitro (outside the body) to provide diagnostic information.
- Mechanism: The assay measures the inhibition of platelet function by using agonists and modifiers on a blood sample. This is a classic in vitro diagnostic approach.
The fact that it's used with the Thrombelastograph (TEG) Hemostasis Analyzer, which is also an IVD device, further supports this classification. The TEG Platelet Mapping Assay is a reagent kit used with the analyzer to perform a specific in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TEG® Platelet Mapping Assay is intended for use with the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide. For Professional Use Only.
Product codes
JOZ
Device Description
The TEG Platelet Mapping Assay consists of a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF, which when used on a heparinized blood sample can measure the inhibition of platelet function.
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 Use Only.
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
The TEG Platelet Mapping Assay was subjected to testing to verify the reliability of the assay and to demonstrate substantial equivalence. Test results demonstrate that the TEG reliably detects a reduction in platelet function (aggregation) in the presence of anti-platelet drugs, and that the TEG measurements correlate well with the optical aggregometry method.
Key Metrics
Not Found
Predicate Device(s)
Thrombelastograph® Coagulation Analyzer (TEG®) 5000 Series, Chrono-log Corp. Optical Aggregation Systems and Reagents
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).
0
SEP = 1 2004
510(k) Summary
K041502
Submitter's Name / Contact Person
| Haemoscope Corporation | Eli Cohen, Ph.D. |
|---|---|
| 5693 West Howard Street | President and CEO |
| Niles IL 60714 | Tel: (847) 588-0453 / (800) 438-2834 |
General Information
| Device Trade Name | Thrombelastograph® (TEG®) Platelet Mapping™ Assay |
|---|---|
| Common / Usual Name | Platelet Aggregation Assay |
| Classification Name | Automated Platelet Aggregation System |
| Classification | This device has been classified by the Hematology and Pathology |
| Devices Panel (81) into Class II (21 CFR 864.5700). |
Device Description
The TEG Platelet Mapping Assay consists of a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF, which when used on a heparinized blood sample can measure the inhibition of platelet function.
Intended Use
The TEG Platelet Mapping Assay is intended for use with the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofibin, or eptifibatide. For Professional Use Only.
Predicate Devices
The TEG Platelet Mapping Assay is substantially equivalent to the following devices:
- Thrombelastograph® Coagulation Analyzer (TEG®) 5000 Series .
- . Chrono-log Corp. Optical Aggregation Systems and Reagents
Summary of Studies
The TEG Platelet Mapping Assay was subjected to testing to verify the reliability of the assay and to demonstrate substantial equivalence. Test results demonstrate that the TEG reliably detects a reduction in platelet function (aggregation) in the presence of anti-platelet drugs, and that the TEG measurements correlate well with the optical aggregometry method.
Conclusion
The data and information provided in this submission demonstrate substantial equivalence and support clearance of the 510(k) premarket notification for the TEG Platelet Mapping Assay.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eli Cohen, Ph.D. President and CEO Haemoscope Corporation 5693 West Howard Street Niles Illinois 60714
SEP - 1 2004
Rc: K041502
Trade/Device Name: Thrombelastograph® (TEG®) Platelet Mapping™ Assay Regulation Number: 21 CFR § 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: II Product Code: JOZ Dated: June 4, 2004 Reccived: June 7, 2004
Dear Dr. Cohen:
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 I·DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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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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.
Sinccrely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D., 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
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| 510(k) Number (if known): | K041502 |
|---|---|
| Device Name: | Thrombelastograph ® (TEG ® ) Platelet Mapping TM Assay |
Indications For Use:
The TEG® Platelet Mapping Assay is intended for use with Intended Use: the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide.
Joachim Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041502
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)