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.

AI/ML Overview

The Dade PFA-100 Platelet Function Analyzer is intended to aid in the detection of platelet dysfunction in citrated human whole blood for patients with a suspected disorder of primary hemostasis.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state pre-defined acceptance criteria. Instead, it compares the performance of the proposed device (PFA-100) to a predicate device (Chrono-log Aggregometer) to demonstrate substantial equivalence. The reported performance of both devices is presented below:

Metric	Proposed Device (PFA-100)	Predicate Device (Chrono-log Aggregometer)
Clinical Sensitivity	96.1%	97.4%
Clinical Specificity	88.6%	91.5%
Overall Agreement	90.1%	-

The study concludes that the Clinical Sensitivity and Specificity of the proposed device are "statistically comparable" to those of the predicate device, indicating that the device meets the implied acceptance of being equivalent to the existing market standard.

2. Sample Size and Data Provenance for the Test Set:

Sample Size: A total of 328 specimens were tested.
- 176 samples were from subjects with normal platelet function.
- 152 samples were from subjects with platelet dysfunction (von Willebrand disease, aspirin-induced dysfunction, and Glanzmann's thrombasthenia).
Data Provenance: The document does not explicitly state the country of origin. The study was a clinical study, which typically implies prospective data collection, but it's not explicitly stated if it was fully prospective or included retrospective components. The samples were collected from subjects representing 63% females and 37% males.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was explicitly described in the provided text. The study focused on comparing the device's performance to a predicate device, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The "Clinical Sensitivity" and "Clinical Specificity" values reported for the "Proposed Device PFA-100" represent its standalone performance in detecting platelet dysfunction. The overall agreement with the predicate device also indicates its standalone performance compared to an existing method.

7. Type of Ground Truth Used:

The Platelet Function Status for each sample (used as the ground truth) was based upon "results from a platelet function test panel and clinical history." This suggests a combination of objective clinical laboratory tests and expert clinical judgment.

8. Sample Size for the Training Set:

The document does not mention a separate "training set" or its sample size. The study described appears to be a validation study for the device, comparing its performance to a predicate using the entire collected dataset. This type of device relies on established biological principles and may not involve a machine learning training phase in the traditional sense.

9. How Ground Truth for the Training Set Was Established:

As no separate training set is mentioned, this information is not applicable.

Summary

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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 AnalyzerDade® PFA Collagen/Epinephrine Test CartridgeDade® PFA Collagen/ADP Test CartridgeDade® PFA Trigger Solution
Common or Usual Name:	PFA-100 system
Classification Name:	None
Registration Number:	Manufacturing Sites (Reagents)Dade International, Inc.1851 Delaware ParkwayMiami, FL 33125	1017272
	Dade International, Inc.2173 99th Ave.Miami, FL 33172	1025506
	Manufacturing Site (Instrument)Dade International, Inc.Microscan Division2040 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 DevicePFA-100	Predicate DeviceChrono-log Aggregometer
Clinical Sensitivity	96.1%	97.4%
Clinical Specificity	88.6%	91.5%

C 2 4

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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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Page 2

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)

.. *

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).