Quality Control Material, Genetics, Dna
The Quality Control Material, Genetics, DNA (product code NZB) is an in vitro diagnostic device providing DNA quality control materials, including synthetic DNA controls and cell-line-based controls, used in genetic test systems to estimate precision and detect systematic analytical deviations arising from reagent or instrument variation. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.5910 within the Microbiology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NZB
- Device Class
- FDA class 2
- Regulation Number
- 866.5910
- Medical Specialty
- Microbiology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093737 | HEMOSIL F11 & FV DNA CONTROL | May 04, 2010 | Substantially Equivalent | Instrumentation Laboratory CO |
| K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | Dec 16, 2008 | Substantially Equivalent | Maine Molecular Quality Controls, Inc. |
| K063224 | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL | Dec 22, 2006 | Substantially Equivalent | Gentris Corporation |
| DEN060007 | INTROL CF PANEL I CONTROL | Oct 12, 2006 | Unknown | Maine Molecular Quality Controls, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.