21 CFR §892.1001

1. (a)Identification. The liver iron concentration imaging companion diagnostic for deferasirox is an image processing device intended to aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox. The device calculates a numeric value for liver iron concentration based on magnetic resonance images acquired under controlled conditions. The calculated numeric value is used to assess the need for deferasirox treatment and for monitoring treatment in patients with non-transfusion-dependent thalassemia. The liver iron concentration imaging companion diagnostic for deferasirox is essential to the safe and effective use of deferasirox in patients with non-transfusion-dependent thalassemia.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Design verification and validation must include nonclinical and clinical performance testing demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements.
   2. (2)Labeling must include specifying:
      1. (i)Instructions for acceptance testing of images prior to processing;
      2. (ii)Data processing quality assurance protocols; and
      3. (iii)The sensitivity and specificity of liver iron concentration measurements.