(a) Identification. An anti-tumor necrosis factor alpha monoclonal antibody test system is an in vitro diagnostic device intended for the measurement of an anti-tumor necrosis factor alpha monoclonal antibody as an aid in the management of patients with Crohn's disease or ulcerative colitis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include the following:

(i) Detailed documentation of studies that demonstrate the analytical performance of the device for its intended use, including for each analyte and device output. These studies must demonstrate analytical performance for each monoclonal antibody analyte and device output that is adequate to support all intended clinical uses, including all of its indications for use, and testing environments. These studies must include precision, reproducibility, linearity, accuracy, high dose hook effect, sample stability, detection limits (including limit of blank, limit of detection, and limit of quantification) and analytical specificity studies, or alternative approaches determined to be appropriate by FDA.

(ii) Detailed documentation of data that is adequate to support the accuracy of the device and/or device performance for all intended clinical uses, including all of its indications for use, as determined to be appropriate by FDA.

(iii) Detailed documentation demonstrating traceability of the device to an internationally recognized reference material, as determined to be appropriate by FDA.

(2) The labeling required under § 809.10(b) of this chapter must include limiting statements including the following:

(i) The device should not be used for conditions other than Crohn's disease or ulcerative colitis.

(ii) The test result is intended as an aid in the management of the patient, and not to be used to replace clinical judgment.

[91 FR 57495, Sept. 10, 2026]