(225 days)
Not Found
Not Found
No
The summary describes a laboratory test using an impedance-based cell counter to measure platelet aggregation, with no mention of AI or ML technologies.
No.
The device is described as an "in vitro diagnostic screening test" for determining platelet inhibition, which is a diagnostic function, not a therapeutic one. It analyzes a bodily sample to provide information about a condition rather than treating or preventing it.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is an in vitro diagnostic screening test."
No
The device is described as an in vitro diagnostic screening test on whole blood that uses an electronic impedance-based cell counter. This description clearly indicates the use of hardware (the cell counter) to perform the measurement, making it a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood..."
This clearly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aggregation of functional platelets is measured using an electronic impedance-base cell counter.
Product codes
GHR
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5700 Automated platelet aggregation system.
(a)
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.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Helena Laboratories C/O Patricia Franks P.O. Box 752 1530 Lindbergh Drive Beaumont, TX 77704
FEB 2 3 2007
Re: K061991
Trade/Device Name: Plateletworks Arachidonic Acid Regulation Number: 21 CFR 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: Class II Product Code: GHR Dated: July 7, 2006 Received: July 13, 2006
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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predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0484. 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 (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Iobat Beckerh
Robert L. Becker, Jr., MD, PhD 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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Indications for Use
510(k) Number (if known): ΚΟΘ(99/
Plateletworks Arachidonic Acid Device Name: Indications for Use:
Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aqqreqation of functional platelets is measured using an electronic impedance-base cell counter.
Tobe M. Beckerf
Division Sign-Off
510(k) K061997
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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