AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

K163274 · Aggredyne, Inc. · JOZ · Apr 5, 2017 · Hematology

Device Facts

• Record ID: K163274
• Device Name: AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
• Applicant: Aggredyne, Inc.
• Product Code: JOZ · Hematology
• Decision Date: Apr 5, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

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.

Device Story

AggreGuide A-100 is an instrument for analyzing platelet-aggregation-induced light scattering. Device uses laser diode to generate light; light interacts with platelet samples; scattering signals are measured to assess aggregation. Modifications include replacement of laser diode with QSI QL78165A-L; updated Quality Control (QC2) cartridge using fixed diffuser instead of rotating groove; software revision (v5.10) to support QC2; shelf-life extension for test cartridges to 19 months. QC2 testing uses steady light for optics verification and oscillating light for amplifier verification. Device operates in clinical settings; provides pass/fail results for QC and platelet aggregation data for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation activities included laser diode performance testing, QC2 implementation verification, software validation, and stability testing (isochronous paradigm) to support 18-month shelf life.

Technological Characteristics

Laser light scattering system. Components: instrument and disposable cartridges. Laser diode: QSI QL7816SA-L. Agonist: 1 mM Arachidonic Acid. Sample: 164 μL 3.2% citrated whole blood. Connectivity: Factory calibrated. Software: Version 5.10. Risk management: ISO 14971:2007.

Indications for Use

Indicated for use with the AggreGuide A-100 Instrument and AggreGuide A-100 AA assay for the analysis of platelet-aggregation-induced light scattering.

Regulatory Classification

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.

Predicate Devices

• AggreGuide A-100 Instrument and AggreGuide A-100 AA assay (K122162)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

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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 Road<br>Suite 150<br>Houston, TX 99077 |
| Phone: | 713-636-5996<br>866-800-1955 |
| Contact: | Philip Speros, Ph.D.<br>[e-mail] |

## 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

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.

# 5. 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.

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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 Concentration<br>Used for Platelet<br>Activation | 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 Volume<br>Required | 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 Control<br>Cartridge | QC quality control cartridge for instrument self-check | Modified quality control QC2<br>cartridge |
| 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.