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Last synced on 18 April 2025 at 11:05 pm
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subpart-f—immunological-test-systems/
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Quality Control Material, Genetics, Dna

Page Type
Product Code
Definition
Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.
Physical State
This type of device includes synthetic DNA controls and cell-line based controls.
Technical Method
No method, quality control material
Target Area
No target area, IVD
Regulation Medical Specialty
Microbiology
Review Panel
Immunology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
866.5910
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
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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]

FDA Browser

by Innolitics

IM/
subpart-f—immunological-test-systems/
NZB
View Source

Quality Control Material, Genetics, Dna

Page Type
Product Code
Definition
Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.
Physical State
This type of device includes synthetic DNA controls and cell-line based controls.
Technical Method
No method, quality control material
Target Area
No target area, IVD
Regulation Medical Specialty
Microbiology
Review Panel
Immunology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
866.5910
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
View Source

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]