Diagnostics in vitro

Device Legislation. Regulations covering medical devices define reagents used in in vitro diagnostic tests as devices (see Medical diagnostic reagents Prosthetic and biot dicaldevices). 

Community-wide regulation of medical devices commenced with the introduction of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Two further base directives followed that cover all other medical devices The Medical Devices Directive 93/42/EEC and The In Vitro Diagnostics Directive 98/79/EC. All three base directives are similar in content and structure. However, it should be noted that, in addition to dealing with the particular subject matter, the Medical Devices Directive and the In Vitro Diagnostics Directive also contained amendments to the previous device directives. The Medical Devices Directive amended articles in the Active Implantable Medical Devices Directive, while the In Vitro Diagnostics Directive amended articles in the Medical Devices Directive. 

The sampling kit consists of the labelled urea, which is a drug a sampling straw, which is a device and a sample container, which would be considered an in-vitro diagnostic (IVD) medical device under EU definitions. Other examples of diagnostic drug products used in conjunction with medical devices include dyes administered to visualise blocked veins and arteries. 

CAUTION Contains a biological product for investigational in-vitro diagnostic tests only . 

Studies to investigate the safety and effectiveness of In Vitro Diagnostic (IVD) medical devices under intended use conditions are conducted as performance evaluations. They are considered to present less risk than clinical investigations since, by their nature, studies involving IVDs cannot have any direct impact on the health and safety of trial subjects. 

In-vitro diagnostic reagents for field trial studies should bear the statement For Investigational Use Only. The performance characteristics of this product have not been established. ... 

EN 375 Information supplied by the manufacturer with in-vitro diagnostic... 

EN 592 Instructions for use for in-vitro diagnostic instruments for self-testing... 

IVDI In-vitro diagnostic medical device For performance evaluation... 

In Vitro Diagnostics Directive 98/79/EC, Article 10 (Registration of manufacturers), Article 11 (Vigilance procedure Competent Authorities), Aimex 1115 (manufacturer s vigilance and reporting duties)... 

The application and development of new in vitro diagnostic techniques aims to enable physicians to reach an allergy diagnosis with no risk for the patient. This is particularly desirable in the case of serious reactions such as anaphylaxis, by confirming the existence of an anaphylactic reaction and differentiating between individuals which present with sensitization but no cUnical symptoms following exposure to the allergen from those that show a serious clinical reaction. 

The p-lactams (penicillins and their derivatives) are the drugs which most frequently cause IgE-mediated anaphylactic reactions. Diagnosis is based on skin tests. To date, the best vaUdated in vitro diagnostic methods are specific IgE and BAT. As for the determination of specific IgE using ImmimoCap (Phadia AB, Uppsala, Sweden), the sensitivity of the technique in the diagnosis of immediate reaction to (3-lactams with positive skin test ranges, according to the study, from 37 to 54% with a specificity of between 83 and 100% [23,24]. 

Reactions not mediated by IgE but produced by a pharmacologic reaction predominantly by the NSAID inhibitors COX-1 and -2 which can cause respiratory, skin or both types of reaction or severe anaphylaxis. These are the most frequent types of reaction. To date, only BAT has been validated as an in vitro diagnostic test with contrasted usefulness. In the best argued study [32], sensitivity of the test... 

Recent developments in Europe mean that reference materials included in diagnostic kits are covered by the recent directive controlling the production and use of in vitro diagnostic devices, and must be licensed before use. 

Tumor markers are tumor-associated analytes that are used in patients with known malignancy (carcinoma, sarcoma, lymphoma, etc., which have been diagnosed and confirmed by biopsy). Tumor marker in vitro diagnostic (IVD) tests are... 

Aziz, K. J. New approaches to the evaluation of in vitro diagnostic devices. J. Clin. Ligand Assay 18,255-256(1995). 

Since Congress gave it authority to regulate in vitro diagnostic tests in 1976, the FDA has included assessment of clinical validity based on data made available by the test s developer (Holtzman, 2000). In view of the paucity of published data on predictive values of pharmacogenetic tests, and the likelihood that many of them will be low (Table 9.2), data on clinical validity should be required before pharmacogenetic tests are used clinically.12... 

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