---
kind: "section"
citation: "21 C.F.R. § 866.5910"
title: "21"
number: "866.5910"
heading: "Quality control material for cystic fibrosis nucleic acid assays."
url: "https://uscodex.org/cfr/21/866.5910"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 866.9](/cfr/21/866.9.md). 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)](/cfr/21/866.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[72 FR 1176, Jan. 10, 2007, as amended at 84 FR 71811, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[72 FR 1176, Jan. 10, 2007, as amended at 84 FR 71811, Dec. 30, 2019]