VITROS TDM Performance Verifier is prepared from bovine serum to which therapeutic drugs, inorganic salts, and preservatives have been added.

Transcription

1 VITROS Chemistry Products TDM Performance Verifier I, II, and III TDM Performance Verifier I, II, and III Rx ONLY Intended Use For in vitro diagnostic use only. VITROS Chemistry Products TDM Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Reagents VITROS TDM Performance Verifier is prepared from bovine serum to which therapeutic drugs, inorganic salts, and preservatives have been added. Warnings and Precautions For in vitro diagnostic use only. WARNING: While these products are bovine in origin, they should be handled using the same precautions as with any other blood or blood-derived product. WARNING: Contains ProClin 300 (CAS ) 1 VITROS TDM Performance Verifiers contain ProClin 300. H317: May cause an allergic skin reaction. P280: Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352: IF ON SKIN: Wash with plenty of soap and water. P333 + P313: If skin irritation or rash occurs: Get medical advice/ attention. P363: Wash contaminated clothing before reuse. Refer to for the Safety Data Sheets and for OCD contact information. WARNING Not all products and systems are available in all countries. Reconstitution No reconstitution is necessary. Version 10.1 Pub. No. J11412_EN 1 of 5

2 TDM Performance Verifier I, II, and III INSTRUCTIONS FOR USE Storage Storage Storage and Stability Reagent Storage Condition Stability Unopened Frozen -18 C ( 0 F) Until expiration date Opened Refrigerated 2 8 C (36 46 F) Store tightly stoppered * * Refer to the Assay Sheet for analyte-specific stability information. Materials Provided 6 vials (2 ml each) of VITROS Chemistry Products TDM Performance Verifier I 6 vials (2 ml each) of VITROS Chemistry Products TDM Performance Verifier II 6 vials (2 ml each) of VITROS Chemistry Products TDM Performance Verifier III Procedure The VITROS TDM Performance Verifier should be assayed in the same manner as a patient sample. The reported value can then be compared with the Range of Means and within-lab standard deviation (SD) on the assay sheet. Caution: Do not use visibly damaged product or product with incompletely sealed packaging. 1. Allow vials to thaw. 2. Mix the vial thoroughly by gently inverting several times. DO NOT SHAKE. 3. Remove the seal and stopper from each vial just prior to use. Keep all vials tightly stoppered when not in use. 4. Place fluid in a cup and cover with a pierceable cap. 5. Restopper the vial and immediately return it to the refrigerator. 6. Bring the cup to room temperature, C (64 82 F), before analysis (approximately 10 minutes for refrigerated material). 7. Analyze according to the operating instructions for your system. 8. Discard any unused portion in the cup following testing. Assay Values References Verify that the fluid lot number on the assay sheet is the same as the lot number printed on the vial label. Use the Range of Means provided for the reagent generation in use. Results exceeding the published Range of Means should be investigated. Each laboratory should establish its own analyte-specific mean. Each laboratory should evaluate and, if necessary, update the mean after each reagent lot change. The within-lab standard deviation (SD) published on the assay sheet for a given analyte may be used as the laboratory s baseline SD for any reagent lot. Refer to assay-specific instructions for use for additional performance information. 1. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/ of 5 Pub. No. J11412_EN Version 10.1

3 Glossary of Symbols TDM Performance Verifier I, II, and III Glossary of Symbols Date of Revision Version Description of Technical Changes* Added USA to legal manufacture address Updated EC Representative address Prescription Use Statement added Warnings and Precautions: added reference updated Hazard and Precaution Statements to align with the new Safety Data Sheets added Globally Harmonized Symbol to comply with the Classification, Labelling and Packaging (CLP) Regulations References: added reference Glossary of Symbols: added Globally Harmonized Symbols to comply with the Classification, Labelling and Packaging (CLP) Regulations Glossary of Symbols: added Date of Manufacture Glossary of Symbols: updated Added information for the VITROS 4600 Chemistry System Version 10.1 Pub. No. J11412_EN 3 of 5

4 TDM Performance Verifier I, II, and III INSTRUCTIONS FOR USE Date of Revision Version Description of Technical Changes* Added information for the VITROS 5600 Integrated System Warnings and Precautions Removed subsections containing standard laboratory safety guidelines; added statement Procedure Added Caution Assay Values Added information Minor wording changes Warnings and Precautions: added warning Warnings and Precautions Removed unnecessary warning Assay Values Wording update Glossary of Symbols Updated data New organization and sections consistent with IVD Directive 2002APR English only New format, technically equivalent to 2000MAR27. * The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document. When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory policies, as appropriate. Signature Obsolete Date 4 of 5 Pub. No. J11412_EN Version 10.1

5 TDM Performance Verifier I, II, and III Ortho-Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF35 5PZ United Kingdom Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY USA VITROS is a registered trademark of Ortho-Clinical Diagnostics, Inc. Ortho-Clinical Diagnostics, Inc., Version 10.1 Pub. No. J11412_EN 5 of 5