FDA product code NZB: Quality Control Material, Genetics, Dna
NZB is the FDA product code for quality control material, genetics, dna. It is a Class II device, regulated under 21 CFR 866.5910 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under NZB, from 3 different applicants. The average 510(k) review took 87 days (median 59). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Quality Control Material, Genetics, Dna |
| Device class | Class II |
| Regulation | 21 CFR 866.5910 |
| Review panel | IM — Immunology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NZB clearance
Top NZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 1 | 2010-05-04 |
| Maine Molecular Quality Controls, Inc. | 1 | 2008-12-16 |
| Gentris Corporation | 1 | 2006-12-22 |
Most recent NZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093737 | Instrumentation Laboratory CO | HEMOSIL F11 & FV DNA CONTROL | 2010-05-04 | 151 |
| K083171 | Maine Molecular Quality Controls, Inc. | INTROL CF PANEL I CONTROL, MODEL: G106 | 2008-12-16 | 50 |
| K063224 | Gentris Corporation | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL | 2006-12-22 | 59 |
Recalls for NZB devices
openFDA lists no recalls for product code NZB.
Frequently asked questions
What is FDA product code NZB?
NZB is the FDA product code for quality control material, genetics, dna. It is a Class II device, regulated under 21 CFR 866.5910 and reviewed by the Immunology panel.
What device class is NZB?
Class II, regulation 21 CFR 866.5910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NZB?
Across 3 cleared submissions the average was 87 days from receipt to decision (median 59).
Which companies have the most NZB clearances?
Instrumentation Laboratory CO (1); Maine Molecular Quality Controls, Inc. (1); Gentris Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NZB
- Run a recall and safety report across every NZB manufacturer
- Watch product code NZB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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