FDA 510K for Direct-To-Consumer Access Pharmacogenetic Assessment System
A Direct-To-Consumer (DTC) Access Pharmacogenetics Assessment System is a service that enables individuals to directly access insights into how their genetic makeup may affect their response to medications. By analyzing genetic variants that influence drug efficacy, safety, and dosage, this system provides valuable information to guide personalized treatment plans. It empowers consumers to make informed decisions about their healthcare in partnership with their healthcare providers, ensuring more tailored and effective medication choices.
Intended Use of Direct-To-Consumer Access Pharmacogenetics Assessment System
It is pharmacogenetics Tests under the FDA, which means it outlines the requirements for medical devices that analyse an individual’s genetic makeup to predict their potential reaction to certain medications; essentially, these are considered “direct-to-consumer” genetic tests related to drug response
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Pharmacogenetic Assessment System
FDA 510K for Pharmacogenetic Assessment System Device Code and Regulation Number
| Sr.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | QDJ | Direct-To-Consumer Access Pharmacogenetic Assessment System | Direct-To-Consumer Access Pharmacogenetic Assessment System | 862.3364 | 2 |
Direct-To-Consumer Access Pharmacogenetic Assessment System
Intended Use
The Direct-to-consumer access system is a genetic testing system that analyses DNA from saliva to detect and interpret genetic variants, providing users with information to discuss with healthcare professionals.
Device Description
A Direct-To-Consumer Access Pharmacogenetic Assessment System is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only and is intended for direct access testing by lay users.
The physical composition of this device includes reagents and instrumentation designed for nucleic acid sequence analysis and the interpretation of pharmacogenetic associations related to detected genetic variations. It provides pharmacogenetic insights through lay-user reports.
The technical functionality involves measuring and analyzing nucleic acid sequences to identify genetic variants and interpret their pharmacogenetic relevance. The target area includes a sample collection device and a molecular diagnostic test for genetic analysis. It is used as over the counter use.
Performance Testing (Analytical) for Pharmacogenetic Assessment System
- Qualitative genetic test
- Accuracy
- Precision (Reproducibility and Repeatability)
- Minimum DNA Input (MDI)
- Shelf life
Clinical Testing
No Guidance available for 510k submission