510(k) Report

FDA product code · Microbiology

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

OEPClass II21 CFR 866.3980510(k) required1 decision since 20140 recalls

1 FDA decision since 2014. No recall names this code. The most-cited predicate is K140851, named by 1 later device.

A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the…

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 OEP 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 · OEP

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OEP

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

Recalls per year · OEP

No recall names OEP since 2007.

Adverse event reports per year · OEP

No MAUDE report names OEP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—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 — OEP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OEP? 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 OEP devices cite most?

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

  • K140851Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 20141cites it

Which OEP devices have the deepest lineage?

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

  • K140851Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 20146generations

What has FDA decided in OEP lately?

  • K140851Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention · 2014

The one OEP decision →

Related product codes

Other codes under 21 CFR 866.3980.

OZY Chlamydophila Pneumoniae Dna Assay SystemOMG Antisera, Fluorescent, Human MetapneumovirusOCC Respiratory Virus Panel Nucleic Acid Assay…OZX Mycoplasma Pneumoniae Dna Assay SystemOOU Parainfluenza Multiplex Nucleic Acid AssayOEM Human Metapneumovirus (Hmpv) Rna Assay SystemOZE Influenza A And Influenza B Multiplex Nucleic…OTG Non-Sars Coronavirus Multiplex Nucleic Acid…OZZ Bordetella Pertussis Dna Assay System