ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

K020914 · Helena Laboratories · JBP · May 23, 2002 · Hematology

Device Facts

• Record ID: K020914
• Device Name: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
• Applicant: Helena Laboratories
• Product Code: JBP · Hematology
• Decision Date: May 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7140
• Device Class: Class 2

Intended Use

The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

Device Story

Actalyke XL Analyzer and test tubes measure activated clotting time (ACT) in whole blood. System used in clinical settings including bypass, vascular, and transplant surgeries, cardiac catheterization, and coronary angioplasty. Operated by healthcare professionals to monitor coagulation status during procedures. Provides quantitative ACT results to assist clinicians in managing anticoagulation therapy, potentially improving patient safety during invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

In vitro diagnostic analyzer for activated whole blood clotting time (ACT). System includes analyzer unit and specialized test tubes. Operates via measurement of blood coagulation kinetics.

Indications for Use

Indicated for patients undergoing bypass, vascular, or transplant surgery, cardiac catheterization, and coronary angioplasty requiring activated clotting time (ACT) monitoring.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia Franks Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752

MAY 2 3 2002

Re: k020914

> Trade/Device Name: Actalyke® XL Analyzer Regulation Number: 21 CFR § 864.7140 Regulation Name: Activated Whole Blood Clotting Time Test Regulatory Class: II Product Code: JBP Dated: March 1, 2002 Received: March 21, 2002

Dear Ms. Franks:

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

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## 510(k) Number (if known): H

Device Name: Artalyke XL

## Indications For Use:

The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

Josephine Bautista
(Division Sign Off)

Page

(Division Sian-Off) Division of Clinical Laboratory Devices 510(k) Number.

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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)