510(k) Report

FDA product code · Microbiology

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

NXDClass II21 CFR 866.3332510(k) required3 decisions since 20060 recalls

3 FDA decisions since 2006. No recall names this code. The most-cited predicate is K080570, named by 8 later devices.

Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with…

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, microbiology panel

Twenty years of NXD 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 · NXD

1in 2010

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

2026 to Oct 25, outlined.

Median 510(k) review, days · NXD

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

Recalls per year · NXD

No recall names NXD since 2007.

Adverse event reports per year · NXD

No MAUDE report names NXD 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 — NXD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NXD? 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 NXD devices cite most?

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

  • K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention · 20088cite it
  • DEN060008Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe SetCenters for Disease Control and Prevention · 20062cite it

Which NXD devices have the deepest lineage?

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

  • K100287Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136U.S. Army Medical Material Development Command · 20102generations
  • K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention · 20081generation

What has FDA decided in NXD lately?

  • K100287Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136U.S. Army Medical Material Development Command · 2010
  • K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention · 2008
  • DEN060008Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe SetCenters for Disease Control and Prevention · 2006

All 3 NXD decisions →

Related product codes

Other codes under 21 CFR 866.3332.

OMS Novel Influenza A Virus, A/H5 Ns1 ProteinOQW 2009 H1n1 Influenza Virus (Swine Origin)…