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Classification of in vitro diagnostic reagents
In China, most in vitro diagnostic reagents are managed according to medical devices, and some in vitro diagnostic reagents are managed according to drugs. According to drug administration, in vitro diagnostic reagents for blood source screening and in vitro diagnostic reagents labeled with radionuclides are mainly used. All in-vitro diagnostic reagents listed on the market should be registered or filed by the drug supervision and administration department, and the classification of in-vitro diagnostic reagents based on the relevant medical device registration certificate or filing certificate should be obtained.
According to the level of product risk from low to high, in vitro diagnostic reagents are classified into the first, second and third categories
The first kind of in vitro diagnostic reagent products,
It mainly includes:
(1) Microbial culture medium (not used for microbial identification and drug sensitivity test);
(2) Sample processing products, such as hemolytic agents, diluents, dyes, etc.
Category II in vitro diagnostic reagent products, mainly
(1) reagents for protein detection;
(2) reagents for sugar detection;
(3) reagents for hormone detection;
(4) Reagents for enzyme detection;
(5) reagents for ester detection;
(6) Reagents for vitamin detection;
(7) Reagents for the determination of inorganic ions;
(8) Reagents for the detection of drugs and drug metabolites;
(9) Reagents for autoantibody detection;
(10) Reagents for microbial identification or drug sensitivity testing;
(11) Reagents for the detection of other physiological, biochemical or immunological indicators.
The third category of in vitro diagnostic reagent products,
It mainly includes:
(1) Reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens;
(2) Reagents related to blood group and tissue type;
(3) Reagents related to human gene detection;
(4) Reagents related to hereditary diseases;
(5) Reagents related to the detection of narcotic drugs, psychotropic drugs and toxic drugs for medical use;
(6) Reagents related to the detection of therapeutic drug targets;
(7) reagents related to the detection of tumor markers;
(8) Reagents related to allergens.
Manifestations of in vitro diagnostic reagents
In vitro diagnostic reagents are not all liquid, but also have other manifestations such as test paper.
In vitro diagnostic reagents are mainly used for in vitro detection of human samples, including reagents, kits, calibrators, quality control products and other products.
Nomenclature of in vitro diagnostic reagent products
The naming of in vitro diagnostic reagents should follow the following principles:
Product names can generally be composed of three parts. The first part is the name of the substance under test; the second part is the use, such as diagnostic serum, test kit, quality control products; the third part is the method or principle, such as enzyme-linked immunosorbent assay, colloidal gold assay, etc. This part should be listed in brackets.
If there are many components or other special circumstances, the product-related indications or other alternative names may be used.
Class I products, calibration products and quality control products shall be named according to their intended uses.
Do in vitro diagnostic reagents need to be registered for testing before they go on sale?
When applying for the registration of category II and III in vitro diagnostic reagents, registration tests shall be carried out. The production of registered test samples shall meet the relevant requirements of the quality management system of medical devices, and clinical trials or applications for registration shall be conducted only if the registered test is qualified.
When the first kind of in vitro diagnostic reagent is filed, the product self-examination report shall be submitted.
Should clinical trials be conducted before in vitro diagnostic reagents are approved for marketing?
The first kind of in vitro diagnostic reagent should be registered without clinical trial.
Clinical trials should be conducted when applying for the registration of category II and III in vitro diagnostic reagents.
In any of the following cases, clinical trials may be exempted:
(1) The reaction principle is clear, the design is finalized, the production technology is mature, the same kind of in vitro diagnostic reagent has been on the market for many years and no serious adverse events have been recorded. Without changing the conventional use, the applicant can provide the evaluation data of equivalence with the products on the market;
(2) The safety and effectiveness of the in vitro diagnostic reagent can be demonstrated by the evaluation of clinical samples covering the expected uses and interfering factors.
Expected use of in vitro diagnostic reagent products
The expected uses of in vitro diagnostic reagent products are generally approved by the drug supervision and administration department. They are scientific and legal, such as "assistant diagnosis" and "diagnosis", "early diagnosis", "screening", "therapeutic monitoring", "individualized drug use" (concomitant diagnosis), etc. At the same time, quantification should be marked on the instructions. Testing or qualitative testing, sample type requirements, etc.
The intended use of the product must be consistent with the corresponding content in the product registration or filing certification documents.