1.0 Abbott RealTime IDH2 Labeling 1.1 Abbott RealTime IDH2 Amplification Reagent Kit Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 2 of 35 1.2 Abbott RealTime IDH2 Oligonucleotide Reagent 1 Label 1.3 Abbott RealTime IDH2 Oligonucleotide Reagent 2 Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 3 of 35 1.4 Abbott RealTime IDH2 Oligonucleotide Reagent 3 Label 1.5 Abbott RealTime IDH2 Oligonucleotide Reagent 4 Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 4 of 35 1.6 Abbott RealTime IDH2 Activation Reagent Label 1.7 Abbott RealTime IDH2 DNA Polymerase Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 5 of 35 1.8 Abbott RealTime IDH2 Control Kit Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 6 of 35 1.9 Abbott RealTime IDH2 Positive Control Label 1.10 Abbott RealTime IDH2 Negative Control Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 7 of 35 1.11 Abbott RealTime IDH2 m2000rt Application CD-ROM Disc Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 8 of 35 1.12 Abbott RealTime IDH2 m2000rt Application CD-ROM Carton Label Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 9 of 35 Abbott RealTime IDH2 m 2000rt Application CD-ROM 08N82-001 Version 1.0 51-603271/R1 08N82-001 51-603271/R1 Intended Use Key to Symbols Used The Abbott RealTime IDH2 m2000rt Application CD-ROM, Version 1.0 (List No. 08N82-001) Reference Number is intended for use with the Abbott Realtime IDH2 Assay (List No. 08N82) on the m2000 Instrument. Abbott RealTime IDH2 m2000rt Application CD-ROM, Version 1.0 Lot Number (List No. 08N82-001) contains the RealTime IDH2 assay application files that can be installed for use on the Abbott m2000rt System. In Vitro Diagnostic Medical Device The following are important facts to know before installing this Assay CD-ROM version: • The Abbott RealTime IDH2 m2000rt Version Application CD-ROM, Version 1.0 can only be used with m2000rt System Software Version 8.0 and higher. Consult instructions for use • To install the Application Specification Files located on the Abbott RealTime IDH2 m2000rt Application CD-ROM, Version 1.0, follow the instructions found in section 5 of the m2000rt For In Vitro Diagnostic Use System Operations Manual under Application Management. • Once the CD-ROM has been placed in the Manufacturer CD-ROM drive, allow two minutes for the drive to read the CD-ROM before proceeding with the installation instructions. If the CD-ROM Please read the following information prior to will not read, remove and reseat the CD-ROM installing the Abbott RealTime IDH2 m2000rt in the CD-ROM drive and again allow two Application CD-ROM, Version 1.0 on your minutes to read. m2000rt System. Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 10 of 35 Assay Specific Information Application Name Version File Path Name RealTime IDH2 1.00 d:\AppSpecificationFiles\RealTime_IDH2_v1.0.asy Host Configuration For Configuration of your host, please refer to the following table. Assay Name Assay ID IDH2 IDH2 Important: Please retain this document in your m2000rt System Operations Manual for documentation of assay file versions available on this CD-ROM. For additional technical assistance, please contact your Area Customer Support. Abbott Molecular Inc. 1300 East Touhy Avenue Des Plaines, IL 60018 USA © 2016 Abbott Laboratories www.abbottmolecular.com October 2016 51-603271/R1 Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 11 of 35 Abbott RealTime en IDH2 Control Kit 08N82-080 51-608431/R1 08N82-080 51-608431/R1 Key to Symbols Used warnings AND PRECAUTIONS In Vitro Diagnostic Medical Device List Number For In Vitro Diagnostic Use In Vitro Diagnostic Medical Device • Consult Abbott RealTime IDH2 package insert instructions for use. Lot Number • Do not use beyond expiration date. • The and vials are intended for single use In Vitro Test only; remaining reagents after first use should be discarded. For In Vitro Diagnostic Use The controls contain sodium azide and 2-methyl-2H-isothiazol-3-one, which Product of USA is a component of ProClin 950. Abbott RealTime IDH2 Negative Control Prescription Use Only Abbott RealTime IDH2 Positive Control The following warnings apply: Use by Warning Negative Control H 317 May cause an allergic skin reaction. Positive Control EUH032 Contact with acids liberates very toxic gas. P261 Avoid breathing mist / vapours / spray. Temperature Limit P280 Wear protective gloves / protective clothing / eye protection. Consult instructions for use P272 Contaminated work clothing should not be allowed out of the workplace. P302+P352 IF ON SKIN: Wash with plenty of water. Warning P333+P313 If skin irritation or rash occurs: Get medical advice / attention. Manufacturer P362+P364 Take off contaminated clothing and wash it before reuse. CUSTOMER SERVICE: 1-800-553-7042 P501 Dispose of contents / container in accordance with local regulations. This package insert must be read carefully prior to use. Package insert instructions must be followed accordingly. Reliability of assay results cannot Safety Data Sheet Statement: Important information regarding the safe be guaranteed if there are any deviations from the instructions in this handling, transport, and disposal of this product is contained in the Safety package insert. Data Sheet. NAME STORAGE INSTRUCTIONS Abbott RealTime IDH2 Control Kit -15°C The Abbott RealTime IDH2 Control Kit must be stored at –25 to –15°C. IntenDED Use -25°C The Abbott RealTime IDH2 Controls are used to establish run validity of Shipping ConDitions Abbott RealTime IDH2 when used for the qualitative detection of single The product is shipped on dry ice. nucleotide variants (SNVs) coding nine IDH2 mutations (R140Q, R140L, If assay reagents are received in a condition contrary to the label R140G, R140W, R172K, R172M, R172G, R172S, and R172W) in DNA recommendation, or are damaged, contact Abbott Technical Services. extracted from human blood (EDTA) or bone marrow (EDTA). Technical assistance REAGENTS For technical assistance, call Abbott Molecular Technical Services at Abbott RealTime IDH2 Control Kit 1-800-553-7042 or visit the Abbott Molecular website at (List No. 08N82-080) http://www.abbottmolecular.com. 1. Abbott RealTime IDH2 Negative Control Abbott RealTime is a trademark of Abbott Laboratories. (List No. 8N82Z) (5 vials, 0.210 mL per vial). < 0.01% noninfectious All other trademarks are property of their respective owners. plasmid DNA in a buffered solution with carrier DNA. Preservatives: sodium azide and 0.15% ProClin® 950. 2. Abbott RealTime IDH2 Positive Control (List No. 8N82W) (5 vials, 0.210 mL per vial). < 0.01% noninfectious plasmid DNA in a buffered solution with carrier DNA. Preservatives: © 2017 Abbott Laboratories sodium azide and 0.15% ProClin 950. www.abbottmolecular.com The Abbott RealTime IDH2 Control Kit must only be used with the Abbott August 2017 RealTime IDH2 Amplification Reagent Kit (List No. 08N82-090). 51-608431/R1 1 Abbott RealTime IDH2 PMA 170005 - Amendment 2 August 2017 Volume 1 001_Administrative Documents and IDH2 PMA Amendment 2_mw001 Page 12 of 35 Abbott RealTime IDH2 en 08N82-090 08N82-090 51-608430/R1 51-608430/R1 ONLY Key to Symbols Used INDICATION FOR USE Abbott RealTime IDH2 is indicated as an aid in identifying acute myeloid List Number leukemia (AML) patients with an isocitrate dehydrogenase - 2 (IDH2) mutation for treatment with IDHIFA® (enasidenib). In Vitro Diagnostic Medical Device This test is for prescription use only. Lot Number SUMMARY AND EXPLANATION OF THE TEST Abbott RealTime IDH2 detects single nucleotide variants (SNVs) In Vitro Test coding nine IDH2 mutations (R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172W) by using PCR technology with For In Vitro Diagnostic Use homogeneous real-time fluorescence detection. The assay uses human Product of USA blood or bone marrow aspirate specimens and reports a qualitative result. Table 1 lists the IDH2 mutations detected by the Abbott RealTime IDH2 assay. Prescription Use Only ONLY Table 1. Mutations Detected by the Abbott RealTime IDH2 Assay Use by Codon IDH2 Mutation SNV Negative Control R140Q CAG R140L CTG Positive Control R140 R140G GGG Contains sufficient for <n> tests R140W TGG R172K AAG Temperature Limit R172M ATG R172 R172G GGG Consult instructions for use R172S AGT and AGC Warning R172W TGG Manufacturer IDH2 (isocitrate dehydrogenase - 2) is a mitochondrial enzyme that helps break down nutrients and generate energy for the cell. The homodimeric enzyme catalyzes a reaction that converts isocitrate to α - ketoglutarate Oligonucleotide Reagent 1 (α - KG) while reducing NADP to NADPH and liberating CO2. Because of its involvement in cellular energy production, IDH2 plays a role in the metabolism of glucose, fatty acids,