Clinical chemistry-specific protein IVDs

Intended purpose

The device is an in vitro diagnostic (IVD) device designed for the quantitative and qualitative detection of matrix metalloproteinase-1 (MMP-1) in human saliva. The test provides: (1) Quantitative measurement of the relative concentration of MMP-1 in saliva. (2) Qualitative results based on a predefined threshold (i.e. 232.7 pg/mL), where a positive result indicates that salivary MMP-1 levels exceed the set cutoff value. The test results are intended to assist healthcare professionals in distinguishing oral squamous cell carcinoma (OSCC) from oral potentially malignant disorders (OPMD) or high-risk individuals. This test is not intended for standalone diagnosis of OSCC or any other disease and should be used in conjugation with clinical evaluation, including an oral mucosal examination and other diagnosis procedures. This product is intended for use only by trained professionals in certified clinical laboratories and healthcare institutions.