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U.S. Department of Health and Human Services

Product Classification

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Device quality control material, genetics, dna
Regulation Description Quality control material for cystic fibrosis nucleic acid assays.
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
Product CodeNZB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible