Section 866.5910 - Quality control material for cystic fibrosis nucleic acid assays(a)Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9 . The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays." See § 866.1(e) for the availability of this guidance document. 72 FR 1176 , Jan. 10, 2007, as amended at 84 FR 71811 , Dec. 30, 2019 As amended at 84 FR 71811 , 12/30/2019