Mr. Med Tech's instant testosterone test has demonstrated analytical and clinical validation metrics that not only meet but exceed FDA performance requirements across all major benchmarks necessary for 510(k) clearance.
 

• ✅ Detection Range: Our test covers 0.07–25 ng/mL, comfortably encompassing the full clinical range for male testosterone levels.

• ✅ Limit of Detection: At 0.07 ng/mL, our LOD surpasses the FDA's expected threshold of ≤ 0.1 ng/mL.

• ✅ Accuracy (Serum): With a slope of 1.02 and R² = 0.98 (versus the FDA threshold of 0.95–1.05 and R² ≥ 0.95), our results align tightly with gold-standard LC-MS/MS benchmarks.

• ✅ Accuracy (Finger-Prick): Slope = 0.98, R² = 0.92, which falls well within the FDA’s required range and reflects consistent performance in real-world use cases.

• ✅ Precision (CV%): Intra-lot precision ranges from 7.9% to 12.8%, outperforming the FDA’s maximum threshold of 15%.

• ✅ Specificity: 100% (30 out of 30) testosterone-free serum samples yielded no false positives, meeting the FDA requirement for diagnostic specificity.

What This Means for Investors
 
These validation results confirm that Mr. Med Tech's test is not only scientifically sound but also regulatory-ready. It is positioned to achieve FDA clearance efficiently under the 510(k) pathway. The strong alignment with FDA expectations also reduces regulatory risk, accelerates time-to-market, and strengthens our licensing and acquisition value. For investors, this positions Mr. Med Tech as a category-defining diagnostics innovator with clear technical, regulatory, and commercial advantages.