Quasar FDA Phase I Implementation kit Available!
At Quasar Instruments, we understand the challenges laboratories face when navigating FDA Laboratory Developed Test (LDT) guidelines. The FDA is applying medical device regulations to laboratory testing workflows, defining an entire process or series of processes as a single device. While many of these requirements make sense for standalone instruments, they become more complex when applied to integrated lab workflows.
Our Interpretation of the FDA’s Approach
Rather than viewing individual components in isolation, we consider the entire testing process—from sample receipt to report release—as one cohesive device.
For urine toxicology testing, this includes:
- Accessioning and sample tracking
- Sample preparation (manual or automated)
- Instrument operation and data acquisition
- Data analysis and review
- Integration with the Laboratory Information System (LIS)
- Final report generation and release
Built for Compliance & Adaptability
The analytical procedure functions as a program, with built-in system checks that identify errors before a reportable result is released. We believe the FDA’s focus is on single-point failure detection—if an error is identified and prevents an inaccurate result from being released, the system is working as intended.
How Our Phase 1 Implementation Kit Helps
✅ Future-Proof Compliance – Our system records multiple data points while allowing labs to define what is reportable. If regulatory definitions change, our system can retroactively adjust reporting parameters to maintain compliance.
✅ Seamless Integration – The kit is designed as a plug-and-play tool, ensuring that labs can implement FDA compliance measures without disrupting existing workflows.
✅ Enhanced Quality Control – By treating the entire process as a device, labs can identify and mitigate single-point failures, ensuring both compliance and operational efficiency.
Moving Forward Together
At Quasar Instruments, we are committed to helping labs navigate regulatory complexity with practical, adaptable solutions. Our Phase 1 Implementation Kit is designed to provide clarity and compliance in an evolving regulatory landscape.
For more information or to discuss how our approach can support your lab, contact us at (877) 535 8001.