The device master file should include the following device descriptive information:— (a) it may include (1) what is detected; (2) its function (for example screening, monitoring, diagnostic or aid to diagnosis, staging or aid to staging of disease); (3) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (4) whether it is automated or not; (5) whether it is qualitative or quantitative; (6) the type of specimen required (e.g. serum, plasma, whole blood, tissue biopsy, urine); (7) testing population; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 117 of 248 (b) the intended user (lay person or professional); (c) a general description of the principle of the assay method; (d) the risk based class of the device; (e) a description of the components (e.g. reagents, assay controls and calibrators) and where appropriate, a description of the reactive ingredients of relevant components (such as antibodies, antigens, nucleic acid primers) where applicable; (f) a description of the specimen collection and transport materials provided with the in vitro diagnostic medical device or descriptions of specifications recommended for use; (g) for instruments of automated assays; a description of the appropriate assay characteristics or dedicated assays; (h) for automated assays; a description of the appropriate instrumentation characteristics or dedicated instrumentation; (i) a description of any software to be used with the in vitro diagnostic medical device; (j) a description or complete list of the various configurations/variants of the in vitro diagnostic medical device that will be made available; (k) a description of the accessories, other in vitro diagnostic medical device and other products that are not in vitro diagnostic medical device, which are intended to be used in combination with the in vitro diagnostic medical device. Reference to the manufacturer's previous device generation(s) or similar devices or device history. 2.2 For a new in vitro diagnostic medical device: Where relevant to demonstrating conformity to the essential principles, and to provide general background information, the device master file may provide a summary of Clinical Performance Evaluation reports. 2.3 For an in vitro diagnostic medical device already available on the market in India: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (i) This information may include a summary of the number of adverse event reports rela ted to the safety and performance of this in vitro diagnostic medical device in relation to the number of in vitro diagnostic medical devices placed on the market. (ii) External certificates and documents which give written evidence of conformity with the essential principles may be annexed to the device master file. (iii) Comparative analysis to prove substantial equivalence to the predicate device(s), if claimed in the application.