Saliva samples: IVD classification terms and rules

Rule 1 

Devices used for the following purposes are classified as category D: detecting the presence of blood, blood components, cells, tissues or organs, or any of their derivatives, or revealing infectious agents, in order to assess whether they are suitable for blood transfusion and organ transplantation Or cell administration. Detect whether there are or reveal infectious agents, which can cause life-threatening diseases and have a high or suspicious transmission risk. Determine the pathogen load of life-threatening diseases, and its monitoring is critical to the process of patient management.

Rule 2 

Devices are expected to be used for blood typing or tissue typing to ensure that the blood, blood components, cells, tissues or organs used for blood transfusion or transplantation or cell administration are immunologically compatible. Such devices are classified as category C , Except for devices used to determine any of the following markers:-ABO system [A (ABO1), B (ABO2), AB (ABO 3)];-Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];-KELL system [Kel1 (K)];-KIdd system [JK1 (Jka), JK2 (Jkb)];-Duffy system [ FY1 (Fya), FY2 (Fyb)], in this case, they are classified as D category.

Rule 3 

The device is classified as category C, if its purpose is: (a) to detect the presence or exposure of sexually transmitted pathogens; (b) to detect whether there is a certain high or suspicious high in the cerebrospinal fluid or blood Pathogens at risk of transmission; (c) Used to detect the presence of pathogens, and if the reported results are wrong, they may cause a major risk of death or severe disability of individuals, fetuses, embryos or their offspring; (d) Prenatal use for women Screening to determine its immune status to the infectious agent; (e) to determine the status of infectious diseases or immune status, if the result of the report will cause the patient's treatment decision to endanger the life of the patient or the patient's offspring; (f) Used for companion diagnosis; (g) Used for disease staging, if the reported result is wrong, it will cause the patient's treatment decision to endanger the life of the patient or the patient's offspring; (h) Used for cancer screening, diagnosis or staging; (i) ) Human genetic testing; (j) It is used to detect the level of medicinal products, substances or biological components. If the reported results are wrong, it will cause the patient's treatment decision to endanger the life of the patient's offspring; (k) For life-threatening diseases Patients with diseases or diseases, for patient management; (l) for screening of congenital diseases of embryos or fetuses; (m) for screening of newborns for congenital diseases, failure to detect and treat these diseases may lead to life-threatening conditions Or severely disabled.

Rule 4 

(a) Self-test devices are classified as category C, except for devices used for pregnancy testing, fertility testing, determination of cholesterol concentration, and detection of bacteria in glucose, red blood cells, white blood cells, and urine samples. These devices are classified as category B. 

(b) Bedside testing equipment is classified according to its own characteristics.

Rule 5 

The following devices are classified as Category A: (a) Products used in general laboratories, accessories without hazardous characteristics, buffers, washing fluids, general culture media and histological stains, and the manufacturer makes them suitable for a specific specific The in-vitro diagnostic process of the inspection; (b) the equipment that the manufacturer uses exclusively for the in-vitro diagnostic process; (c) the sample container.

Rule 6 

Devices not covered by the above classification rules are classified as Class B.

Rule 7 

Devices that do not have quality control products with quantitative or qualitative assignments are classified as Class B.

According to the IVDR Regulation (EU) 2017/746 Appendix VIII classification rules, it is divided into four levels: classA, class B, class C and class D.