PLATELETWORKS

K012723 · Helena Laboratories · JOZ · Sep 28, 2001 · Hematology

Device Facts

• Record ID: K012723
• Device Name: PLATELETWORKS
• Applicant: Helena Laboratories
• Product Code: JOZ · Hematology
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

Indications for Use

Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood on 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 hematology analyzer 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. The device utilizes the Ichor hematology analyzer to measure platelet aggregation in fresh whole blood samples. By comparing platelet counts before and after activation, the system calculates the percentage of platelet aggregation. Clinicians use these results to identify trends suggestive of platelet dysfunction during cardiac interventional procedures. Abnormal findings serve as a screening indicator, necessitating further investigation via conventional platelet aggregometry or other definitive diagnostic methods. The device provides rapid, actionable data to support clinical decision-making regarding patient platelet status in a procedural setting.

Technological Characteristics

In vitro diagnostic screening assay; utilizes Ichor hematology analyzer for whole blood platelet count measurement; principle of operation based on change in platelet count following activation; point-of-care form factor.

Indications for Use

Indicated for in vitro diagnostic screening of % platelet aggregation in fresh whole blood during cardiac interventional procedures. Used as a screening tool for detecting trends suggestive of platelet dysfunction. Abnormal results require follow-up with definitive testing methods.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 8 2001

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

Re: K012723

> Trade/Device Name: Collagen for Plateletworks™M Regulation Number: 21 CFR § 864.5700 Regulation Name: System, Automated Platelet Aggregation Regulatory Class: II Product Code: JOZ Dated: August 13, 2001 Received: August 15, 2001

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

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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 Sutman

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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Korz 723 510(k) Number (if known):

Plateletworks™ Device Name:

Indications for Use:

Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood accermination on ong cardiac interventional procedures as measured by a change in platelet count due to activation of functional It may be used at the point-of-care on the Ichor platelets. hematology analyzer 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.

Josephine Santidei

510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)