(280 days)
No
The device description details a mechanical and biological process for measuring platelet function based on blood flow occlusion time. There is no mention of algorithms, data analysis beyond simple time measurement, or any characteristics indicative of AI/ML. The performance studies compare the device's output (Closure Time) to a predicate device and clinical categorization, not to an AI/ML model's output.
No.
The device is for aiding in the detection of platelet dysfunction, which is a diagnostic purpose, not a therapeutic one. It simulates in vitro processes to evaluate platelet function.
Yes
The "Intended Use / Indications for Use" states that the device is "To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis," which indicates its role in identifying a medical condition.
No
The device description clearly states it is an "instrument and test reagents" and describes physical components like a capillary, sample reservoir, membrane, and the application of vacuum. This indicates it is a hardware device with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "To aid in the detection of platelet dysfunction in citrated human whole blood". This indicates the device is used to examine a sample taken from the human body (whole blood) to provide information about a medical condition (platelet dysfunction).
- Device Description: The description details how the device simulates a biological process in vitro (in a test tube or laboratory setting) using "citrated human whole blood" and "test reagents". It measures a biological parameter (Closure Time) based on the interaction of the blood sample with the device's components.
- Sample Type: The device uses "citrated human whole blood", which is a biological specimen taken from a human.
- Purpose: The purpose is to "aid in the detection of platelet dysfunction", which is a diagnostic purpose.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis.
Product codes
JOZ
Device Description
The Dade® PFA-100™ system is an instrument and test reagents in which the process of platelet adhesion and aggregation following a vascular injury is simulated in vitro. Platelet dysfunction detected by the PFA-100 system may be acquired, inherited or induced by platelet inhibiting agents.
The PFA-100 system allows for rapid evaluation of platelet function on small samples of anticoagulated whole blood. The single use test cartridge reagents consists of a number of integrated parts including a capillary, a sample reservoir and a biologically active membrane with a central aperture. By application of a constant vacuum, anticoagulated whole blood is aspirated from the sample reservoir through the capillary and the aperture under standardized rheological conditions that expose platelets to high shear stress. The membrane is coated with collagen and one additional agonist. At the beginning of a test, Trigger Solution is dispensed to wet the membrane. Similar to the in vivo mechanism, platelets adhere and aggregate at the aperture thereby gradually diminishing and finally arresting the blood flow. The instrument determines the time from the start of the test until the platelet plug occludes the aperture, and reports that time interval as the Closure Time. Platelet plug formation in the PFA-100 system is dependent on adequate platelet activity and adequate von Willebrand factor status. Therefore, the Closure Time is an indicator of the platelet function in the analyzed whole blood sample.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Data to support substantial equivalence to the predicate device was generated in a clinical study. The clinical study was designed to demonstrate the substantial equivalence between the PFA-100 (proposed device) and the Chrono-log Aggregometer (predicate device) by comparing the clinical specificity and clinical sensitivity between the systems. A total of 328 specimens were tested with the proposed and the predicate devices. This population, which represented 63% females and 37% males, consisted of 176 samples from subjects with normal platelet function and 152 samples with platelet dysfunction. The group of platelet dysfunction samples were obtained from subjects with von Willebrand disease, aspirin-induced dysfunction, and Glanzmann's thrombasthenia. The Platelet Function Status of each sample was based upon results from a platelet function test panel and clinical history.
Clinical sensitivity and specificity of the proposed and predicate device were calculated against the Platelet Function Status. The Clinical Sensitivity and Specificity of the proposed device are statistically comparable to the calculated clinical sensitivity and specificity for the predicate device. The overall agreement by direct comparison of clinical categorization between the proposed and predicate devices was calculated at 90.1%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Proposed Device PFA-100: Clinical Sensitivity 96.1%, Clinical Specificity 88.6%
Predicate Device Chrono-log Aggregometer: Clinical Sensitivity 97.4%, Clinical Specificity 91.5%
Predicate Device(s)
Reference Device(s)
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).
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NOV 17 1997
510(k) Summary of Safety and Effectiveness Information Dade® PFA-100™ Platelet Function Analyzer Dade® PFA Collagen/Epinephrine Test Cartridge Dade® PFA Collagen/ADP Test Cartridge Dade® PFA Trigger Solution February 7, 1997
Dade International, Inc. 2173 NW 99th Avenue Miami, FL 33172 Contact Person: Bryan Schneider at 305-592-2311 extension 5769, or by facsimile at 305-392-5622
| Trade or Proprietary Name: | Dade® PFA-100™ Platelet Function Analyzer
Dade® PFA Collagen/Epinephrine Test Cartridge
Dade® PFA Collagen/ADP Test Cartridge
Dade® PFA Trigger Solution | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Common or Usual Name: | PFA-100 system | |
| Classification Name: | None | |
| Registration Number: | Manufacturing Sites (Reagents)
Dade International, Inc.
1851 Delaware Parkway
Miami, FL 33125 | 1017272 |
| | Dade International, Inc.
2173 99th Ave.
Miami, FL 33172 | 1025506 |
| | Manufacturing Site (Instrument)
Dade International, Inc.
Microscan Division
2040 Enterprise Blvd.
West Sacramento, CA 95691 | 2919016 |
The Dade PFA-100™ system is substantially equivalent in intended use to the Chrono-log Aggregometer, manufactured by Chrono-log Corporation, Haverton, PA, that was previously cleared under Document Control Nos. K771198, K830749 and K851025. The associated Chrono-log aggregation reagents were most recently cleared under Document Control No. K922800.
The Dade® PFA-100™ system is an instrument and test reagents in which the process of platelet adhesion and aggregation following a vascular injury is simulated in vitro. Platelet
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510(k) Premarket Notification Dade® PFA-100™ Platelet Function Analyzer Dade® PFA Collagen/Epinephrine Test Cartridge Dade® PFA Collagen/ADP Test Cartridge Dade® PFA Trigger Solution Attachment D, Page 2
dysfunction detected by the PFA-100 system may be acquired, inherited or induced by platelet inhibiting agents.
The PFA-100 system allows for rapid evaluation of platelet function on small samples of anticoagulated whole blood. The single use test cartridge reagents consists of a number of integrated parts including a capillary, a sample reservoir and a biologically active membrane with a central aperture. By application of a constant vacuum, anticoagulated whole blood is aspirated from the sample reservoir through the capillary and the aperture under standardized rheological conditions that expose platelets to high shear stress. The membrane is coated with collagen and one additional agonist. At the beginning of a test, Trigger Solution is dispensed to wet the membrane. Similar to the in vivo mechanism, platelets adhere and aggregate at the aperture thereby gradually diminishing and finally arresting the blood flow. The instrument determines the time from the start of the test until the platelet plug occludes the aperture, and reports that time interval as the Closure Time. Platelet plug formation in the PFA-100 system is dependent on adequate platelet activity and adequate von Willebrand factor status. Therefore, the Closure Time is an indicator of the platelet function in the analyzed whole blood sample.
Data to support substantial equivalence to the predicate device was generated in a clinical study. The clinical study was designed to demonstrate the substantial equivalence between the PFA-100 (proposed device) and the Chrono-log Aggregometer (predicate device) by comparing the clinical specificity and clinical sensitivity between the systems. A total of 328 specimens were tested with the proposed and the predicate devices. This population, which represented 63% females and 37% males, consisted of 176 samples from subjects with normal platelet function and 152 samples with platelet dysfunction. The group of platelet dysfunction samples were obtained from subjects with von Willebrand disease, aspirin-induced dysfunction, and Glanzmann's thrombasthenia. The Platelet Function Status of each sample was based upon results from a platelet function test panel and clinical history.
Clinical sensitivity and specificity of the proposed and predicate device were calculated against the Platelet Function Status. The Clinical Sensitivity and Specificity of the proposed device are statistically comparable to the calculated clinical sensitivity and specificity for the predicate device. The overall agreement by direct comparison of clinical categorization between the proposed and predicate devices was calculated at 90.1%.
| | Proposed Device
PFA-100 | Predicate Device
Chrono-log Aggregometer |
|----------------------|----------------------------|---------------------------------------------|
| Clinical Sensitivity | 96.1% | 97.4% |
| Clinical Specificity | 88.6% | 91.5% |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 17 1997
Mr. Bryan Schneider . Senior Regulatory Specialist Requlatory Affairs Dade International Inc. P.O. Box 520672 Miami, FL 33152-0672
Re : K970505/S2 Dade PFA-100 Platelet Function Analyzer Requlatory Class: II Product Code: JOZ Dated: August 25, 1997 Received: August 26, 1997
Dear Mr. Schneider:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beater in 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 leqally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: Dade PFA-100 Platelet Function Analyzer
Indications For Use:
To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis.
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division di Clinic Laboratory Devices
510(k) Number K970505
Prescription Use 0 (Per 21 CFR 801.109)
.. *
OR
Over-The-Counter Use
(Optional Format 1-2-96)