(44 days)
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Not Found
No
The provided text does not mention AI, ML, or related concepts, and the device description is not available.
No
The device is described as an "in vitro diagnostic screening assay" used to detect trends suggestive of platelet dysfunction, which means it is used for diagnosis, not treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Plateletworks is an in vitro diagnostic screening assay".
No
The device is described as an "in vitro diagnostic screening assay" that is used "on the Ichor hematology analyzer." This strongly suggests a physical device (the analyzer) is required for the assay to function, making it a hardware-dependent system, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that Plateletworks is an in vitro diagnostic screening assay. This is the primary indicator that the device is intended for use outside of the body to examine specimens (in this case, fresh whole blood) for diagnostic purposes.
- Specimen Type: The assay is performed on fresh whole blood, which is a biological specimen commonly used in in vitro diagnostics.
- Purpose: The purpose is to determine "% platelet aggregation" and detect "trends suggestive of platelet dysfunction," which are diagnostic measurements related to a patient's health status.
The other sections, while providing additional context about the device's use and setting, do not contradict the initial statement that it is an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
JOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
point-of-care
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them, resembling a bird in flight.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)