21 CFR 892.1001 — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1001
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PCS | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | 2 | 3 | SaMD |
Special Controls
PCS — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
In combination with the general controls of the FD&C Act, the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox is subject to the following special controls: (1) Labeling must specify instructions for acceptance testing of images prior to processing. (2) Labeling must specify data processing quality assurance protocols. (3) Labeling must specify the sensitivity and specificity of liver iron concentration measurements. (4) Nonclinical and clinical performance testing must be included in the premarket notification submission demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements.
De Novo Order DEN130012
PCS — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
*Classification.* Class II (special controls). The special controls for this device are:(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) Labeling must include specifying: (i) Instructions for acceptance testing of images prior to processing; (ii) Data processing quality assurance protocols; and (iii) The sensitivity and specificity of liver iron concentration measurements.
eCFR
PCS — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
(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) Labeling must include specifying: (i) Instructions for acceptance testing of images prior to processing; (ii) Data processing quality assurance protocols; and (iii) The sensitivity and specificity of liver iron concentration measurements.
Ecfr Llm
