RAPIDTEG TEG-ACT TEST

K062604 · Haemoscope Corp. · JBP · Jan 31, 2007 · Hematology

Device Facts

• Record ID: K062604
• Device Name: RAPIDTEG TEG-ACT TEST
• Applicant: Haemoscope Corp.
• Product Code: JBP · Hematology
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7140
• Device Class: Class 2

Intended Use

The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.

Device Story

RapidTEG™ TEG®-ACT Test is an in vitro diagnostic assay used with the Thrombelastograph® (TEG®) Hemostasis System to monitor heparin anticoagulation. The test utilizes whole blood samples to measure clotting time. The system transforms mechanical signals from blood coagulation into quantitative data, providing clinicians with real-time information on patient coagulation status. Used in clinical settings, the device assists healthcare providers in managing heparin therapy. The output allows for informed clinical decision-making regarding anticoagulation levels, potentially benefiting patients by optimizing heparin dosing and reducing risks associated with improper anticoagulation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison to the predicate device.

Technological Characteristics

In vitro diagnostic test for use with Thrombelastograph® Hemostasis System. Measures whole blood clotting time to monitor heparin anticoagulation. Quantitative assay. Operates via mechanical sensing of clot formation within the TEG® system.

Indications for Use

Indicated for monitoring heparin anticoagulation in adult patients using the Thrombelastograph® (TEG®) Hemostasis System.

Regulatory Classification

Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Predicate Devices

• TEG®-ACT Test (K950203)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 stripes forming its wing and tail feathers. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HAEMOSCOPE Corporation C/O Eli Cohen 6231 West Howard Street Niles, Illinois 60714

Re: k062604

JAN 3 1 2007

Trade/Device Name: Rapid TEG®-ACT Test Regulation Number: 21 CFR 864.7140 Regulation Name: Activated Whole Blood Clotting Time Test Regulatory Class: Class II Product Code: JBP Dated: August 31, 2006 Received: September 1, 2006

Dear Mr. 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 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 (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. 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours.

Robert L. Beckerf

Robert L. Becker, Jr., MD, PhD 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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cc: HFZ-401 DMC

HFZ-404 510(k) Staff
HFZ-404 510(k) Staff
D.O.
D.O.
D.O.

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## INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): __

062604

Device Name: RapidTEG™ TEG®-ACT Test

Indications for Use:

The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.

Prescription Use_ V AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062604