K Number

Device Name

AGGREGUIDE

Manufacturer

AGGREDYNE, INC.

Date Cleared

2013-12-20

(518 days)

Product Code

JOZ

Regulation Number

864.5700

Intended 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 antiplatelet 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K042423

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser light scattering system that measures platelet aggregation based on physical principles, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No.
The device is a diagnostic tool designed to detect platelet dysfunction, not to treat it.

Diagnostic

Yes

The intended use explicitly states that it is a "qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion," which aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of an instrument and a disposable assay cartridge, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's a "qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion... in 3.2% citrated venous whole blood". This indicates it's 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 analyzes a "whole blood sample" using "laser light scattering" to measure "platelet aggregation". This is a classic description of an in vitro diagnostic test.
Sample Type: The device uses "3.2% citrated venous whole blood", which is a biological sample taken from a patient.
Purpose: The purpose is to "aid in the detection of platelet dysfunction", which is a diagnostic purpose.

All these factors align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

JOZ

Device Description

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

18 years of age or older

Intended User / Care Setting

professional use

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

Clinical testing: One hundred sixty nine (n=169) healthy subjects were screened for study of the sensitivity of the AggreGuide A-100 in identifying platelet dysfunction due to aspirin ingestion. One hundred thirty eight (n=138) subjects were given an aspirin dose of 325 mg (1 adult non-coated fablet) and tested with the AggreGuide for aspirin induced platelet dysfunction within 2 -30 hours.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing: Non-clinical testing was carried out on the AggreGuide A-100 instrument for electrical safety and electromagnetic interference, as well as software validation against multiple standards. Non-clinical studies were also carried out to assess simple and complex precision, shelf life of the AA reagent, interfering substances, limit of blank (LOB), inter-instrument variability, and lot-to-lot variability. These studies showed that the AggreGuide A-100 System raised no safety concerns when used for the Intended Use.

Sensitivity: 115/138 (83%) CI (95%): 76% - 89%

Pre 325mg Aspirin:
True Negative: 90% (151/167), 95% CI: (85%; 94%)
False Positive: 10% (16/167), 95% CI: (6%; 15%)

Post 325mg Aspirin:
False Negative: 17% (23/138), 95% CI: (11%; 24%)
True Positive: 83% (115/138), 95% CI: (76%; 89%)

The combination of non-clinical and clinical performance test results shows that the instrument performs in a substantially equivalent manner to the predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: 83%
True Negative: 90%
False Positive: 10%
False Negative: 17%
True Positive: 83%

Predicate Device(s)

K042423

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

K122162 DEC 2 0 2013
510(k) (Traditional) Submission

Section 5, 510(k) Summary

510(k) Summary December 18, 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Aggredyne, Inc., AggreGuide A-100.

Company making the submission: 1.

Name:	Aggredyne, Inc.
Address:	10530 Rockley Road
Suite 150
Houston, Texas 77099
Telephone:
Toll Free
Fax:	713-636-5996
866-800-1955
281-317-1874
Contact:	Edward R. Teitel, MD, JD, MBA
E-Mail:	eteitel@aggredyne.com

1. Device Name:

| Trade/Proprietary
Name: | AggreGuide A-100 and
AggreGuide A-100 AA Assay |
|----------------------------|---------------------------------------------------|
| Common/Usual
Name: | Aggregometer |
| Classification Name: | System automated platelet
aggregation |
| Regulation Number: | 864.5700 |
| Product Code: | JOZ |

1. Predicate Devices:
  The predicate is the Accumetrics VerifyNow-Aspirin Assay [K042423].
1. Description of Device:
  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 Page 1 of 4

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.

1. Intended Use Statement:
  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 antiplatelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
1. Summary of the technological characteristics of the device compared to predicate device:
  The AgareGuide A-100 and Accumetrics VerifyNow® agaregometers both measure platelet aggregation in response to arachidonic acid (AA). In the presence of AA, platelets may be activated and aggregate. These aggregates occur when activated platelets in motion come into contact with other activated platelets. In both the AggreGuide A-100 and the VerifyNow® the AA is freeze dried and pre-loaded into disposable, single use cartridges. The AgareGuide detects the aggreaates in whole blood as they pass by the optical window by light scattering. The VerifyNow® detects platelet aggregation at its optical window by measuring light transmittance. With the AggreGuide, the more active the platelets, the more aggregates are formed and the higher the Platelet Activity Index (PAI). With the VerifyNow®, the more active the platelets, the more light transmittance and the higher the Aspirin Reactive Units (ARU). Conversely, if the platelets are inhibited by aspirin, they are not activated by AA to form aggregates. Therefore, few, if any, aggregates form and the AggreGuide shows a low PAI, and, similarly, the VerifyNow® shows a low ARU. The AggreGuide's PAI, like the

VerifyNow's® ARU is a function of the number of aggregates that form in the blood.

1. Performance Testing:
  Non-clinical testing: Non-clinical testing was carried out on the AggreGuide A-100 instrument for electrical safety and electromagnetic interference, as well as software validation against multiple standards. Non-clinical studies were also carried out to assess simple and complex precision, shelf life of the AA reagent, interfering substances, limit of blank (LOB), inter-instrument variability, and lot-to-lot variability. These studies showed that the AggreGuide A-100 System raised no safety concerns when used for the Intended Use.

Site	Sensitivity	CI (95%)
All Sites	115/138 (83%)	76% - 89%

Aspirin 325 mg Absent		Total
≥4 PAI
(Platelet dysfunction not
detected)