The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

Device Description

The AggreGuide A-100 is a laser light scattering system that detects the level of platelet aggregation induced by arachidonic acid agonist in whole blood in motion. The system consists of an instrument and a disposable assay cartridge with pre-loaded freeze dried agonist. A whole blood sample is added to a disposable cartridge that is preloaded with freeze dried arachidonic acid agonist (AA) in a reaction chamber for an individual test. The amount of platelet aggregation is measured by detecting the laser light scattering caused by platelet aggregates. Aspirin is known to inhibit the level of platelet aggregation, or activity, when blood is mixed with arachidonic acid.

AI/ML Overview

My apologies, but this document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, especially in the context of a conventional medical device study (e.g., diagnostic accuracy, comparative effectiveness).

Here's why and what the document does provide:

Why the requested information is not present:

This is a 510(k) Substantial Equivalence Submission for MODIFICATIONS, not an original submission or a study report. The document details changes made to an already cleared device (K122162). Its purpose is to demonstrate that the modified device is still substantially equivalent to the original, cleared device, and that the modifications do not raise new questions of safety or effectiveness.
The document focuses on verification and validation of changes: The "Summary of Performance Data" (Section 7) explicitly states that "The risk analysis method used to assess the impact of the modifications was ISO 14971:2007, 'Medical devices -- Application of risk management to medical devices'." It then lists results for specific changes: laser diode part replacement, QC2 implementation, software updates, shelf life extension, and User's Manual revision.
No clinical performance data was collected for this submission: Section 8 explicitly states, "The modifications did not require collection of clinical performance data." This directly contradicts the need for most of the information you asked for (e.g., sample size for test set, ground truth, expert adjudication, MRMC studies, standalone performance).

What the document does provide (related to your request, but not directly answering it):

Device Name: AggreGuide A-100 AA assay, AggreGuide A-100 Instrument
Indications for Use: "The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician."
Predicate Device: AggreGuide A-100 AA assay and AggreGuide A-100 Instrument, 510(k) document number K122162.
Specific Modifications:
- Laser Diode Part: Changed from Sanyo DL-4140-001S to QSI QL7816SA-L
- Quality Control Cartridge: Modified to QC2 cartridge
- Software: Updated from Version 4.91 to Version 5.10
- Test Cartridge Shelf Life: Extended from 12 months to 18 months
- User's Manual: Revised from LBL-0014-C to LBL-0014-E

Given this, I cannot fill in the table or provide the specific details you requested because the document is a regulatory submission for changes to an existing device, and clinical performance data was explicitly not required for this submission. The "acceptance criteria" discussed are related to the successful verification and validation of these specific hardware/software/shelf-life changes, not the overall diagnostic accuracy of the device against a clinical ground truth.

If you had a document for the original 510(k) clearance (K122162), it might contain some of the performance data you're looking for, but this particular document does not.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2017

Aggredyne, Inc. Mr. Philip C. Speros Chief Operating Officer 10530 Rockley Road Houston, Texas 77099

Re: K163274

Trade Name: AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument Regulation Number: 21 CFR 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: Class II Product Code: JOZ Dated: November 18, 2016 Received: November 21, 2016

Dear Mr. Speros:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/ Industry/default.htm.

Sincerely yours,

Leonthena R. Carrington -S

Lea Carrington, MS, MBA, MT(ASCP) Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163274

Device Name AggreGuide A-100 AA assay AggreGuide A-100 Instrument

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92(c).

1. Submitter

Name:	Aggredyne, Inc.
Address:	10530 Rockley RoadSuite 150Houston, TX 99077
Phone:	713-636-5996866-800-1955
Contact:	Philip Speros, Ph.D.psperos@aggredyne.com

2. Device

Trade Name(s):	AggreGuide A-100 AA assay
	AggreGuide A-100 Instrument
Common Name:	Platelet aggregation test

The AggreGuide A-100 AA assay and AggreGuide A-100 Instrument are classified as Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for automated platelet aggregation test systems. Product Code: JOZ 21 CFR 864.5700 Regulation Number:

Classification Name: System, Automated Platelet Aggregation

3. Predicate Device

The predicate device(s) used for the determination of substantial equivalence are the previously-cleared AggreGuide A-100 AA assay and AggreGuide A-100 Instrument, 510(k) document number K122162.

4. Device Description

5. Indications for Use

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6. Comparison with Predicate Device

The predicate device(s) used for the determination of substantial equivalence are the previously-cleared AggreGuide A-100 AA assay and AggreGuide A-100 Instrument, 510(k) document number K122162.

Item	Predicate Device (K122162)	Current Device
Device Name	AggreGuide A-100	Same
Regulation Number	864.5700	Same
Product Code	JOZ	Same
Principle of Operation	Platelet aggregation with detection of laser light scattering	Same
Indications for Use	The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.	Same
Intended Use	The AggreGuide device is intended for patients for whom detecting platelet dysfunction in response to arachidonic acid may be desirable, such as those who are on or are candidates for antiplatelet therapy.	Same
Specimen Type	3.2% sodium citrate-anticoagulated whole blood	Same
Test Cartridges	Single-use disposable	Same
Agonist ConcentrationUsed for PlateletActivation	Arachidonic Acid, 1 mM	Same
Test Procedure	Manual addition of blood sample to test cartridge, automated assay and generation of results	Same
Time to Result	5 minutes	Same
Sample VolumeRequired	164 μL	Same
Results Displayed	Platelet Activity Index (PAI)	Same
Calibration	Performed at Factory	Same
Sterility	Not sterile	Same
Laser Diode Part	Sanyo DL-4140-001S	QSI QL7816SA-L
Quality ControlCartridge	QC quality control cartridge for instrument self-check	Modified quality control QC2cartridge
Software	Version 4.91	Version 5.10
Test Cartridge Shelf Life	12 months	18months
User's Manual	LBL-0014-C	LBL-0014-E

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7. Summary of Performance Data

The risk analysis method used to assess the impact of the modifications was ISO 14971:2007, "Medical devices -- Application of risk management to medical devices".

Additional modification-specific criteria were applied to each modification as necessary and as noted in the body of the 510(k).

The results of the laser diode part replacement verification and validation activities demonstrated acceptable performance.

The results of the QC2 implementation process and verification and validation activities demonstrated acceptable performance.

The results of software and design verification and validation activities demonstrated acceptable performance.

The results from stability testing using an isochronous testing paradigm supported the shelf-life extension to 18 months based on acceptance criteria of ±1 PAI unit.

The results of User's Manual revision activities showed acceptable validation and verification results.

8. Conclusions

The modified AggreGuide A-100 AA assay and AggreGuide A-100 Instrument have the following similarities to those which previously received 510(k) clearance:

have the same indicated use,
use the same operating principle,
. incorporate the same basic design,
. incorporate the same reagents, and
. are packaged using the same materials and processes.

The modifications did not require collection of clinical performance data. In addition, the results of design verification and validation tests do not raise new issues of safety and effectiveness.

In summary, the AggreGuide A-100 AA assay and AggreGuide A-100 Instrument described in this submission are, in our opinion, substantially equivalent to the predicate device.

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).