THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

K041502 · Haemoscope Corp. · JOZ · Sep 1, 2004 · Hematology

Device Facts

• Record ID: K041502
• Device Name: THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
• Applicant: Haemoscope Corp.
• Product Code: JOZ · Hematology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

Intended Use

The TEG® Platelet Mapping Assay is intended to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide.

Device Story

TEG Platelet Mapping Assay consists of blood modifiers, ADP and AA platelet agonists, and ActivatorF; used with heparinized blood samples on Thrombelastograph (TEG) Hemostasis Analyzer. Device measures inhibition of platelet function. Used in clinical settings by professionals. Output provides assessment of platelet aggregation reduction in patients on anti-platelet therapy. Healthcare providers use output to monitor drug efficacy and patient coagulation status.

Clinical Evidence

Clinical studies included 500 samples from adults (18-85) comparing TEG to optical aggregometry (r=0.948). Sensitivity/specificity for clopidogrel and aspirin were evaluated in 34 subjects; clopidogrel sensitivity 80%, specificity 86%; aspirin sensitivity 100%, specificity 92% (p≤.001). Additional studies on 10 normal volunteers (aspirin) and 67 cardiac patients (clopidogrel) showed statistically significant (p<.001) reductions in MA values and increased % platelet inhibition post-dosing.

Technological Characteristics

System uses mechanical sensing of clot formation (TEG MA parameter). Components include two-column instrument, computer interface, and software. Consumables: disposable cups and pins. Reagents: ADP, arachidonic acid, Activator F. Connectivity: computer interface module. Calibration: electronic. Sterilization: not specified. Software: hazard analysis and development processes reviewed.

Indications for Use

Indicated for assessing platelet function in patients receiving platelet-inhibiting drugs (aspirin, clopidogrel, abciximab, tirofiban, eptifibatide).

Regulatory Classification

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.

Predicate Devices

• Thrombelastograph® Coagulation Analyzer (TEG®) 5000 Series
• Chrono-log Corp. Optical Aggregation Systems and Reagents

Submission Summary (Full Text)

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### 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: [phone] |

#### 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<br>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 [phone]. 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 [phone] or [phone] 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)