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Dna And Rna Oncology Controls
- Page Type
- Product Code
- Definition
- Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls.
- Physical State
- This device consists of synthetic DNA or RNA pools with multiple different DNA variants or RNA variants in a genomic background.
- Technical Method
- For use with qualitative or quantitative NGS-based assays
- Target Area
- No target area, IVD
- Regulation Medical Specialty
- Microbiology
- Review Panel
- Medical Genetics
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 866.5910
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.5910 Quality control material for cystic fibrosis nucleic acid assays
§ 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]