510(k) Report

FDA product code · Immunology

Quality Control Material, Genetics, Dna

NZBClass II21 CFR 866.5910510(k) exempt4 decisions since 20060 recalls

FDA lists NZB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 2006. No recall names this code. The most-cited predicate is K083171, named by 1 later device.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of NZB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NZB

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZB

Too few NZB 510(k)s in any year since 2007 to give a median.

Recalls per year · NZB

No recall names NZB since 2007.

Adverse event reports per year · NZB

No MAUDE report names NZB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NZB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NZB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NZB devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K083171Introl CF Panel I Control, Model: G106Maine Molecular Quality Controls, Inc. · 20081cites it

Which NZB devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K093737Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO · 20101generation

What has FDA decided in NZB lately?

  • K093737Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO · 2010
  • K083171Introl CF Panel I Control, Model: G106Maine Molecular Quality Controls, Inc. · 2008
  • K063224Gentrisure Human Genomic Dna Reference ControlGentris Corporation · 2006

All 4 NZB decisions →

Related product codes

Other codes under 21 CFR 866.5910.

SCU Dna And Rna Oncology ControlsQIG Quality Control Material, Genetics, Rna