Article 1.The technical specifications set out in the Annex to this...
COMMON TECHNICAL SPECIFICATIONS (CTS) FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
3. COMMON TECHNICAL SPECIFICATIONS (CTS) FOR PRODUCTS REFERRED TO IN ANNEX...
3.1. CTS for performance evaluation of reagents and reagent products for...
3.1.1. Devices which detect virus infections placed on the market for...
3.1.2. Devices intended by the manufacturer for testing body fluids other...
3.1.3. Devices intended by the manufacturer for self-test, i.e. home use,...
3.1.4. All performance evaluations shall be carried out in direct comparison...
3.1.5. If discrepant test results are identified as part of an...
3.1.6. Performance evaluations shall be performed on a population equivalent to...
3.1.7. Positive specimens used in the performance evaluation shall be selected...
3.1.8. Sensitivity with true positives and sero-conversion samples shall be evaluated...
3.1.9. Performance evaluation of screening assays shall include 25 positive (if...
3.1.10. Negative specimens used in a performance evaluation shall be defined...
3.1.11. For performance evaluations for screening assays (Table 1) blood donor...
3.1.12. Devices shall have a specificity of at least 99,5 %...
3.1.13. Devices shall be evaluated to establish the effect of potential...
3.1.14. For devices intended by the manufacturer to be used with...
3.1.15. For devices intended for use with plasma the performance evaluation...
3.1.16. As part of the required risk analysis the whole system...
3.1.17. If a new in vitro diagnostic medical device belonging to...
3.2. Additional requirements for HIV antibody/antigen combined tests
3.3. Additional requirements for nucleic acid amplification techniques (NAT)
3.3.1. For target sequence amplification assays, a functionality control for each...
3.3.2. The analytical sensitivity or detection limit for NAT assays shall...
3.3.3. Genotype detection shall be demonstrated by appropriate primer or probe...
3.3.4. Results of quantitative NAT assays shall be traceable to international...
3.3.5. NAT assays may be used to detect virus in antibody...
3.3.6. For investigation of potential carry-over, at least five runs with...
3.3.7. The whole system failure rate leading to false-negative results shall...
3.4. CTS for the manufacturer’s release testing of reagents and reagent...
3.5. CTS for performance evaluation of reagents and reagent products for...
3.5.1. All performance evaluations shall be carried out in direct comparison...
3.5.2. If discrepant test results are identified as part of an...
3.5.3. Performance evaluations shall be performed on a population equivalent to...
3.5.4. Positive specimens used in the performance evaluation shall be selected...
3.5.5. Devices shall be evaluated to establish the effect of potential...
3.5.6. For devices intended for use with plasma the performance evaluation...
3.6. CTS for the manufacturer’s release testing of reagents and reagent...