510(k) Report

FDA product code · Microbiology

Parainfluenza Multiplex Nucleic Acid Assay

OOUClass II21 CFR 866.3980510(k) required5 decisions since 20090 recalls

5 FDA decisions since 2009. No recall names this code. The most-cited predicate is K091053, named by 3 later devices.

A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture.…

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 OOU 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 · OOU

1in 2017

2009: 12013: 12014: 12015: 12017: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OOU

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

Recalls per year · OOU

No recall names OOU since 2007.

Adverse event reports per year · OOU

No MAUDE report names OOU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20131—00
20141—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OOU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OOU? 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 OOU devices cite most?

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

  • K091053Proparaflu+AssayProdesse, Inc. · 20093cite it
  • K153223ProParaFlu+ AssayHologic, Inc. · 20151cites it
  • K132238Proparaflu+ AssayGen-Probe Prodesse, Inc. · 20131cites it

Which OOU devices have the deepest lineage?

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

  • K172282Panther Fusion Paraflu AssayHologic, Inc. · 20174generations
  • K153223ProParaFlu+ AssayHologic, Inc. · 20153generations
  • K141927Lyra Parainfluenza Virus AssayQuidel Corporation · 20142generations
  • K132238Proparaflu+ AssayGen-Probe Prodesse, Inc. · 20132generations
  • K091053Proparaflu+AssayProdesse, Inc. · 20091generation

What has FDA decided in OOU lately?

  • K172282Panther Fusion Paraflu AssayHologic, Inc. · 2017
  • K153223ProParaFlu+ AssayHologic, Inc. · 2015
  • K141927Lyra Parainfluenza Virus AssayQuidel Corporation · 2014
  • K132238Proparaflu+ AssayGen-Probe Prodesse, Inc. · 2013
  • K091053Proparaflu+AssayProdesse, Inc. · 2009

All 5 OOU decisions →

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 SystemOEM Human Metapneumovirus (Hmpv) Rna Assay SystemOZE Influenza A And Influenza B Multiplex Nucleic…OTG Non-Sars Coronavirus Multiplex Nucleic Acid…OEP Influenza A Virus Subtype Differentiation…OZZ Bordetella Pertussis Dna Assay System