(269 days)
Not Found
No
The summary describes a semi-quantitative assay that measures platelet aggregation using light scattering. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on a calculated index (PAI) with a fixed threshold.
No
The device is an in vitro diagnostic assay used for the detection of platelet dysfunction in patients taking certain antiplatelet drugs, which aids in diagnosis rather than providing direct therapy.
Yes
Explanation: The device is described as an "ADP Assay" used to detect "platelet dysfunction" and determine the "level of platelet aggregation" in patients receiving certain antiplatelet drugs. These functions are characteristic of a diagnostic device, as they are intended to identify a medical condition or state.
No
The device description explicitly states it is an "individual use, disposable assay cartridge for use with the AggreGuide A-100 instrument" and contains "preloaded freeze dried agonist." This indicates a physical hardware component (the cartridge) is integral to the device's function, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "detection of platelet dysfunction in patients... using 3.2% sodium citrated whole blood." This involves testing a biological sample (whole blood) outside of the body to obtain information about a patient's health status (platelet dysfunction).
- Device Description: The device description details how the assay works by detecting and quantifying laser light scattering caused by platelet aggregates in a sample of whole blood. This is a typical method used in in vitro diagnostic tests.
- Care Setting: The intended user is in a "non-CLIA waived physician's office or clinical laboratory," which are common settings for performing in vitro diagnostic tests.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, including blood, tissue, and urine, taken from the human body to detect diseases, conditions, or infections. The AggreGuide A-100 ADP Assay clearly fits this definition.
N/A
Intended Use / Indications for Use
The AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician's office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 29, 2019
Aggredyne, Inc. Philip Speros, COO 10530 Rockley Road. Suite 150 Houston, Texas 77099
Re: K181777
Trade/Device Name: AggreGuide A-100 ADP Regulation Number: 21 CFR 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: Class II Product Code: JOZ Dated: June 29, 2018 Received: July 3, 2018
Dear Philip 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Leonthena R. Carrington -S
Lea Carrington 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
AggreGuide A-100 ADP Assay
Indications for Use (Describe)
The AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician's office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary—K181777 5.0
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 ADP Assay.
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 ADP Assay.
| Name: | Aggredyne, Inc. |
|---|---|
| Address: | 10530 Rockley Road |
| Suite 150 | |
| Houston, Texas 77099 | |
| Telephone: | 713-636-5996 |
| Contact: | Phil Speros |
| E-Mail: | psperos@aggredyne.com |
- Company making the submission: 1.
-
- Device Name:
| Trade/Proprietary
| Name: | AggreGuide A-100 ADP Assay |
|---|---|
| Common/Usual | |
| Name: | ADP platelet function test |
| Classification Name: | System automated platelet |
| aggregation | |
| Regulation Number: | 864.5700 |
| Product Code: | JOZ |
| Class | II |
-
- Predicate Devices:
The predicate is:
- Predicate Devices:
VerifyNow-P2Y12 Assay [K141427]
4
4. Description of Device:
The AggreGuide A-100 ADP Assay is an individual use, disposable assay cartridge for use with the AggreGuide A-100 instrument. The cartridge contains preloaded freeze dried agonist. The level of platelet aggregation induced by the adenosine diphosphate (ADP) agonist in a sample of whole blood is detected within the cartridge. The amount of platelet aggregation is measured by detecting and quantifying the laser light scattering caused by platelet aggregates. P2Y12 inhibitor drugs e.g. clopidogrel, and ticagrelor are known to inhibit the level of platelet aggregation, causing platelet dysfunction.
5. Intended Use Statement:
The AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician's office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values