21 CFR 866.5910 — Quality Control Material, Genetics, Dna
Microbiology (MI) · Part 866 Subpart F—Immunological Test Systems · § 866.5910
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NZB | Quality Control Material, Genetics, Dna | 2 | 4 | |
| QIG | Quality Control Material, Genetics, Rna | 2 | 0 | |
| SCU | Dna And Rna Oncology Controls | 2 | 0 |
Special Controls
NZB — Quality Control Material, Genetics, Dna
The device is classified as Class II under regulation 21 CFR 866.5910 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays" is available at http://www.fda.gov/cdrh/oivd/guidance/1614.html.
De Novo Order DEN060007
NZB — Quality Control Material, Genetics, Dna
*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.
eCFR
NZB — Quality Control Material, Genetics, Dna
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.
Ecfr Llm
QIG — Quality Control Material, Genetics, Rna
*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.
eCFR
SCU — Dna And Rna Oncology Controls
*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.
eCFR
