12. EDMS CLASSIFICATION OF IN VITRO DIAGNOSTIC PRODUCTS...
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B. EDMA Reagent Classification...
- Objective...
- Product Classification...C. EDMA Instrument Classification...
- Product Classification...
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 | A. Foreword to revision 2 |
The first "EDMA Product Classifications for in-vitro Diagnostics Products", prepared by the Association’s Classification Working Party were published in May 1988. The classifications were adopted by the Association in the hope that their widespread observance by those who produce in-vitro Diagnostic products and those who are responsible for producing Diagnostic marketing information would contribute significantly to the improvement of standardisation and reliability of European market information.
These hopes have been fulfilled. Market statistics for in-vitro Diagnostic products have been established in 14 European countries using the "EDMA Classification" for unambiguous definition of the individual product segments.
In 1988 the classification included around 340 individual Diagnostic Parameters comprising 38 groups and 4 major categories.
Significant new product introductions during recent years and some weaknesses which became obvious in the course of using the classification necessitated a comprehensive update of the classification which induced the EDMA Market Research Working Party to prepare the following "In Vitro Diagnostics Product Classification - Revision 2 - 1996".
This Revision 2 includes over 900 individual Diagnostic Parameters comprising 130 subgroups, 46 groups and 5 major categories.
In addition the Working Party has also prepared a Diagnostic Instrument Classification ("Instrument Grouping") which includes a list of about 600 individual instrument names as examples for the corresponding groups.
It has to be recognised that the extent to which the Working Party’s objectives have been achieved will always be a matter of individual judgement. It would be naive for us to assume that the EDMA Classification will meet with unanimous and total agreement. Nevertheless, the many companies who have contributed and participated in its preparation are convinced that this document shows the most logical, practical and relevant In Vitro Diagnostic Reagent and Instrument Classification.
Further modifications and extensions will be necessary in annual updates.
The present Revision 2 - 1996 of the In Vitro Diagnostic Product Classification for Reagents & Instruments has been compiled by the members of the EDMA Market Research Working Party representing several National Associations as well as Corporate Associates.
The MRWP would also like to express their appreciation for the extensive contributions of a large number of employees of the Diagnostic industry throughout Europe which have made this document possible.
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The major purpose of this classification is to record all individual products which are currently available on the market by parameter.
The classification is used in the comprehensive and continuing audit of the In Vitro Diagnostics Market in Europe and in the participating European countries.
The EDMA code numbers identify the individual parameters and which subgroups, groups and categories they belong to.
There are five pairs of digits which describe the different classification levels. The first two digits describe the Category, the second two digits identify the Group within each category, the third pair of digits relate to the Subgroup and the fourth two digits identify the individual Parameter. The last two digits, currently 00, are reserved for the planned breakdown by technical Method, which will be worked out by the MRWP as a next step. (For the current trade association statistics only RIA vs. Non-Isotopic is considered).
For example: 12 03 01 33 00 Prostatic Specific Antigen (PSA)
Level 1 12 = Category.................Immunochemistry Reagents
Level 2 03 = Group..................Tumour Markers
Level 3 01 = Subgroup..........Cancer Antigens
Level 4 33 = Parameter......Prostatic Specific Antigen (PSA)
Level 5 00 = Method........e.g. Non-Isotopic
This system allows to uniquely identify each individual product / parameter and rapidly find them in any listings, e.g. in statistical tables.
There have been several discussions about codification. To avoid any misunderstanding it should be noted that for the use of data processing for statistics, sequential codes are considered appropriate, e.g. starting with 1 for 5’-Nucleotidase and ending with 914 for CMV-Rapid Test. New parameters will then continue with 915 and so on. This is a data processing issue and is not of direct concern for the classification.
cr = cross reference:
In general each parameter exists only once in this classification.
There are a few exceptions, for example: Angiotensin Converting Enzyme is available as Clinical Chemistry parameter as well as Immunoassay. In such cases cr is indicated before the parameter’s name and it is referred to the category and the EDMA-CODE where the other product is allocated to.
11 01 01 09 00 cr Angiotensin Converting Enzyme (CC) IC =>12 06 02 03 00 ACE
12 06 02 03 00 cr Angiotensin Converting Enzyme (IC) CC =>11 01 01 09 00 ACE
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Product ClassificationThe Instrument Classification has been prepared in a very similar way to the existing Reagent Classification. However, there are significant differences and difficulties according to the unequivocalness of product allocation to specific groups and subgroups. To achieve the utmost consent within the whole Diagnostic industry the team has chosen the following procedure:
Level 1 - Categories: The team listed a majority of the existing instruments by brand name and company according to their utilisation for the individual reagent categories (Clinical Chemistry, Immunochemistry, etc.). In the case of "multiple reagent category utilisation" of an instrument the primary field of application was chosen (e.g.: Hitachi 911 can be used for Clinical Chemistry and Immunoassay testing, but primary utilisation is as a Clinical Chemistry Instrument, or DuPont ACA’s primary application is Drugs and not Clinical Chemistry any more, therefore it was grouped as Immunoassay Analyser).
Level 2 - Groups: As a next step within each category the instruments were grouped according to the type of utilisation or specific method (e.g. within the category Immunochemistry Instruments the groups are RIA Equipment, Protein Analyser, Immunoassay Analyser, etc.). Here again the primary field of application was preferred for grouping.
Level 3 - Subgroups: This level includes a mixture of selection criteria for grouping, like: size, dedication, specific methods, degree of automation, etc. Unfortunately, there are no distinct selection criteria available which enable unambiguous product allocation without significant overlaps. For this reason the individual instruments were grouped according to their "competitive aptitude", which means what similar product of another company a customer could choose to achieve the same results, as far as possible. After splitting the whole bunch of instruments into most comparable clusters the most suitable name for the subgroups have been adopted.
The EDMA-code for Instruments consists of three pairs of digits describing the three different classification levels. The first two digits describe the Category, the second two digits identify the Group within each category, the third pair of digits relate to the Subgroup.
Within each subgroup there are instruments listed (grouped) by company and instrument name which fit to the corresponding subgroup.
For example: 23 02 04 5 part differential high end Blood Cell Counter
Level 1 23 = Category....................Haematology Instruments
Level 2 02 = Group......................Blood Cell Counter
Level 3 04 = Subgroup..............5 part differential high end Blood Cell Counter
Examples: 5 part differential high end Blood Cell Counter
Abbott CELL-DYN 3000
CELL-DYN 3500
CELL-DYN 4000
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Bayer H 1 E
H 2
H 3 RTC
H 3 RTX
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Coulter STKR
STKS
MAXM
etc.
____________________________This system allows to uniquely identify each individual instrument and rapidly find them in any listings, e.g. in statistical tables.
| D. General Remarks |
These classifications have been compiled with the best knowledge and conscience of the team members. Numerous comments and suggestions of colleagues of the Diagnostic industry have been adopted. However, nothing is really perfect.The classification will be subject to a yearly update.
Any comments and suggestions for improvements and amendments, especially instruments and companies not yet listed are appreciated and shall be directed at any time to
Dr. Werner Puchegger
Chairman, EDMA Market Research Working Party
Abbott GmbH Diagnostika - WI-Delkenheim / Germany
Tel: (49) 6122 58 - 1550
Fax: (49) 6122 58 - 1217
E-mail: Werner.Puchegger@add.ssw.abbott.com
| E. Download |
Download the EDMA Product Classification for IVDs (Excel format, 861Kb)
| F. Diagnofo Software |