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The ADVIA Centaur® TnI-Ultra® Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur TnI-Ultra assay.
The ADVIA Centaur® Digoxin Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay.

ADVIA Centaur® TnI-Ultra® Master Curve Material is an in vitro diagnostic product containing various levels of bovine cardiac troponin I in a goat serum matrix with preservatives. Each set contains five lyophilized levels (MCM1-5); with a reconstituted volume of 1.0 ml each. MCM1 contains no analyte. The Tnl-Ultra MCMs assigned values are lot-specific of target values 0.00, 1.00, 3.50, 14.0 and 40.0 ng/mL.
ADVIA Centaur® Digoxin Master Curve Materials is an in vitro diagnostic product containing various levels of digoxin in defibrinated human plasma with sodium azide (0.1% after reconstitution) and preservatives. Each set contains six lyophilized levels (MCM1-6); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The Digoxin MCMs assigned values are lot specific of target values 0.0, 0.50, 1.00, 2.00, 3.00, 5.50 ng/mL.

The provided text describes two separate devices: ADVIA Centaur® TnI-Ultra® Master Curve Material (MCM) and ADVIA Centaur® Digoxin Master Curve Material (MCM). Both are quality control materials. I will detail the acceptance criteria and study information for each device independently.

ADVIA Centaur® TnI-Ultra® Master Curve Material (MCM)

1. Table of Acceptance Criteria and Reported Device Performance

• MCM2-5: % dose recovery within 85% to 115% calculated to Day 0
• No adverse trends | Acceptance criteria were met up to the 10 months time point, supporting a shelf-life claim of 9 months. |
  | Stability: In Use (Open Vial) @ 2-8°C (Reconstituted) | - MCM1: Dose recovery ≤ 0.02 dose (versus freshly reconstituted -80°C stored MCM1 average dose)
• MCM2-5: % dose recovery within 85% to 115% (versus freshly reconstituted -80°C stored MCM2-5 average dose) | Acceptance criteria were met up to the 9 hour time point, supporting an open vial claim of 8 hours when stored at 2-8°C. |
  | Stability: In Use (Open Vial) @ -20°C (Reconstituted) | - MCM1: Dose recovery ≤ 0.02 dose (versus freshly reconstituted -80°C stored MCM1 average dose)
• MCM2-5: % dose recovery within 85% to 115% (versus freshly reconstituted -80°C stored MCM2-5 average dose) | Acceptance criteria were met up to the 63 days time point, supporting an open vial (reconstituted) claim stored at -20°C for 60 days. |
  | Stability: On-Board | - MCM1: Dose recovery

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