510(k) Report

510(k) · Cleared

Cleared

Proparaflu+Assay

K091053510(k) TraditionalCleared Nov 20, 2009221-day reviewClass II21 CFR 866.3980

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

Prodesse, Inc. · OOU Parainfluenza Multiplex Nucleic Acid Assay

Cleared on Nov 20, 2009 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) after a 221-day review. Its family tree reaches back 1 generation to 2008. 4 later devices descend from it.

Decided
Nov 20, 2009
Review
221 days
Class
Class II
Product code
OOU
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN070013 (2008). 4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant clearedDEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 200820052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant DEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 20080
  1. Root · 1 generation backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. This deviceK091053 Proparaflu+AssayProdesse, Inc. · 2009
  3. Descendant · cites it directly · 2 of its ownK132238 Proparaflu+ AssayGen-Probe Prodesse, Inc. · 2013
  4. Descendant · cites it directly · 1 of its ownK153223 ProParaFlu+ AssayHologic, Inc. · 2015
  5. Descendant · 2 generations on · 0 of its ownK172282 Panther Fusion Paraflu AssayHologic, Inc. · 2017
  6. Descendant · cites it directly · 0 of its ownK141927 Lyra Parainfluenza Virus AssayQuidel Corporation · 2014

Most influential descendants

Showing 4 of 4 · See all
  • K132238Proparaflu+ AssayGen-Probe Prodesse, Inc. · 2013 · cites it directly2descendants
  • K153223ProParaFlu+ AssayHologic, Inc. · 2015 · cites it directly1descendant
  • K172282Panther Fusion Paraflu AssayHologic, Inc. · 2017 · 2 generations on0descendants
  • K141927Lyra Parainfluenza Virus AssayQuidel Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.2008—
0 (this device)K091053Proparaflu+AssayProdesse, Inc.2009—
+1K132238Proparaflu+ AssayGen-Probe Prodesse, Inc.2013—
+1K153223ProParaFlu+ AssayHologic, Inc.2015—
+2K172282Panther Fusion Paraflu AssayHologic, Inc.2017—
+1K141927Lyra Parainfluenza Virus AssayQuidel Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201710
FIG. 1 — Lineage of K091053, 2008–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OOU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN070013ID-Tag Respiratory Viral Panel
Our reading of the summary gave K063765, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070013, ID-Tag Respiratory Viral Panel (Luminex Molecular Diagnostics, Inc.), granted Jan 3, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
Luminex Molecular Diagnostics, Inc.2008—

Also cleared against DEN070013: 11 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132238Proparaflu+ AssayGen-Probe Prodesse, Inc.20132
K153223ProParaFlu+ AssayHologic, Inc.20151
K141927Lyra Parainfluenza Virus AssayQuidel Corporation20140

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K132238 (Gen-Probe Prodesse, Inc., 2013) has gone furthest, with 2 descendants of its own.
  • 11 other devices also cite its predicate DEN070013.

How does its category compare?

All OOU devices

OOU Parainfluenza Multiplex Nucleic Acid Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the…

Read the full statement (158 words)

The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the

qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus

and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and

purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting

signs and symptoms of respiratory tract infections. This assay targets the conserved

regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-

3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3

nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract

parainfluenza infections if used in conjunction with other clinical and laboratory findings.

This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses.

Negative test results are presumptive and should be confirmed by cell culture. Negative

results do not preclude Parainfluenza 1,2 or 3 virus infections and should not be used as

the sole basis for treatment or other management decisions.

Indications for use as stated in the FDA summary.

Also cleared against DEN070013

11 other devices cite the same predicate.

  • K112781Tag Respiratory Viral Panel Tag Data Analysis Software (Tdas RVP-I)Luminex Molecular Diagnostics, Inc. · 20121 recall
  • K103776Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP FastLuminex Molecular Diagnostics, Inc. · 2011
  • K110968Proflu+ AssayGen-Probe Prodesse, Inc. · 2011
  • K110764Filmarray RP PanelIdaho Technology, Inc. · 2011
  • K103175Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
  • K102952Prodesse ProadenoGen-Probe Prodesse, Inc. · 2010

More from Prodesse, Inc.

6 FDA decisions under this applicant name. See the company

  • K092500Modification to Proflu+ AssayProdesse, Inc. · 2009
  • K090239Progastro CD AssayProdesse, Inc. · 2009
  • K082688Pro HMPV+ AssayProdesse, Inc. · 2008
  • K081030Modification to Proflu+ AssayProdesse, Inc. · 2008
  • K073029Proflu+ AssayProdesse, Inc. · 2008

Recent decisions in OOU

The OOU category page

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

https://510kreport.com/device/K091053 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091053: Proparaflu+Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091053

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026