PLATELETWORKS, MODELS PW-A, PW-C

K023761 · Helena Laboratories · JOZ · Feb 14, 2003 · Hematology

Device Facts

• Record ID: K023761
• Device Name: PLATELETWORKS, MODELS PW-A, PW-C
• Applicant: Helena Laboratories
• Product Code: JOZ · Hematology
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

Indications for Use

Plateletworks (K990398) is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor or Coulter hematology analyzers as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

Device Story

Plateletworks is an in vitro diagnostic screening assay used at the point-of-care to assess platelet function. It utilizes fresh whole blood samples collected during cardiac interventional procedures. The device measures the change in platelet count resulting from the activation of functional platelets. The assay is processed using Ichor or Coulter hematology analyzers. The output is a percentage of platelet aggregation, which clinicians use to identify trends suggestive of platelet dysfunction. Abnormal or suspicious results necessitate repeat testing or further investigation using definitive methods like conventional platelet aggregometry. The device aids in monitoring platelet activity in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic screening assay; utilizes hematology analyzers (Ichor or Coulter) for platelet count measurement; principle of operation based on change in platelet count following activation; intended for point-of-care use.

Indications for Use

Indicated for patients undergoing cardiac interventional procedures to screen for platelet dysfunction by measuring % platelet aggregation in fresh whole blood.

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

• Plateletworks (K990398)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

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

FEB 1 4 2003

Re: k023761

> Trade/Device Name: Plateletworks® Regulation Number: 21 CFR § 864.5700 Regulation Name: Automated Platelet Aggregation System Regulatory Class: II Product Code: JOZ Dated: January 13, 2003 Received: January 14, 2003

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 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

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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.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use:

510(k) Number (if known):

Device Name:

Plateletworks®

Plateletworks (K990398) is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor or Coulter hematology analyzers as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023761 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |