Automated Platelet Aggregation System and 510k Process
An Automated Platelet Aggregation System is a diagnostic instrument designed to assess platelet function by measuring platelet aggregation in response to various agonists. It is primarily used in clinical laboratories to evaluate conditions such as bleeding disorders, thrombocytopathies, and the effects of antiplatelet medications.
Intended Use of Automated Platelet Aggregation System
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.
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 Automated Platelet Aggregation System
Automated Platelet Aggregation System Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | JOZ | System, Automated Platelet Aggregation | Automated Platelet Aggregation System | 864.5700 | 2 |
Automated Platelet Aggregation System (JOZ)
Intended Use: This assay is used in clinical laboratories and healthcare settings to assess platelet function in individuals receiving antiplatelet therapy. It is a semi-quantitative test that measures platelet aggregation, providing an index to evaluate platelet activity.
Device Description: This analytical instrument is designed for in-vitro diagnostic (IVD) applications and is intended for prescription use only. It utilizes disposable single-use cartridges preloaded with freeze-dried reagents, ensuring efficient, accurate, and contamination-free sample processing.
The instrument is equipped with a touchscreen interface, allowing for intuitive data entry and workflow navigation. A detection chamber, integrated with a laser diode and photodetector, analyzes light scatter, enabling precise and real-time measurement of target analytes.
Each single-use cartridge includes a sample well (reaction chamber) and a rotor, which ensures thorough mixing of the sample with the reagent for consistent and reliable analysis. This device is optimized for clinical laboratory and point-of-care settings, offering rapid and accurate results to support diagnostic decision-making.
Performance Testing (Analytical) for Automated Platelet Aggregation System
- Precision (Reproducibility and Repeatability)
- Assay reportable range
- Accuracy
- Traceability
- Sensitivity and Specificity
- Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
- Shelf-life stability
- Transportation stability
- Method comparison
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Applicable for 510k submission and IVDR CE Marking