If All The Individual Test Items In A Joint Detection Reagent Of Multiple Analytes Are In The Catalogue Of IVD Reagents Exempted From Clinical Trials (hereinafter Referred To As The “catalogue”), Can The Multi-analyte Joint Detection Reagent Be Considered As A Product In The Catalogue?

If the applicant can prove that the different individual test items do not interact with each other in the joint detection reagent and the intended use does not exceed the scope of the exemption catalogue, it can be considered the multi-analyte joint detection reagent is just a simple joint of several exempted reagents, and the performance of each test item can be evaluated separately in accordance with the clinical evaluation requirements as the product of the Catalogue. It is worth noting that the applicant should confirm that these test items have a clear significance of joint testing and the additional risks produced by the combination should be evaluated. At the same time, if it has a new clinical significance, the multi-analyte joint detection reagent should not be considered a product that complies with the Catalogue.