510(k) Report

510(k) · Cleared

Cleared

Quidel Molecular RSV + HMPV Assay

K122189510(k) TraditionalCleared Mar 8, 2013227-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

Quidel Corp. · OEM Human Metapneumovirus (Hmpv) Rna Assay System

Cleared on Mar 8, 2013 as substantially equivalent to K092500 (Prodesse, Inc., 2009) and 1 other predicate after a 227-day review. Its family tree reaches back 4 generations to 2008.

Decided
Mar 8, 2013
Review
227 days
Class
Class II
Product code
OEM
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to DEN070013 (2008). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 3 other ancestorsDEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008K081483 · Xtag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008 · recalledK091667 · Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 · Luminex Molecular Diagnostics, Inc. · 2009 · recalledK092500 · Modification to Proflu+ Assay · Prodesse, Inc. · 200920062008201020122014
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor K092500 · Modification to Proflu+ Assay · Prodesse, Inc. · 2009K091667 · Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 · Luminex Molecular Diagnostics, Inc. · 2009 · recalledK081483 · Xtag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008 · recalledDEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 20080
  1. Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. 3 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
  3. 2 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
  4. 1 generation backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
  5. This deviceK122189 Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.2008—
−3K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.20081
−2K091667Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc.20091
−1K092500Modification to Proflu+ AssayProdesse, Inc.2009—
0 (this device)K122189Quidel Molecular RSV + HMPV AssayQuidel Corp.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200830
FIG. 1 — Lineage of K122189, 2008–2013Source: 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 OEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OEM device

  1. #1 K230349 Lyra RSV+hMPV Assayscore 6.2 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (2)

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
*K092500Modification to Proflu+ Assay
Summary page 1
…d assay Product Code - OEM, 0CC Regulation - 21 CER 866.3980 Legally marketed devices to which equivalence is claimed: Gen-Probe Prodesse ProFlu+ (k092500) The ProFIUTM± Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative…
Prodesse, Inc.2009—
*K082688Pro HMPV+ Assay
Summary page 2
…Viral culture should not be afttempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Gen-Probe Prodesse Pro IIMPV+ (k082688) The Pro hMIPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneum…
Prodesse, Inc.2008—

Also cleared against K092500: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K092500.

How does its category compare?

All OEM devices

OEM Human Metapneumovirus (Hmpv) Rna Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OEM

1in 2023

2008: 12011: 12013: 32023: 1
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OEM

34in 2013

2013: 34 days median
2007high 34 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OEM

No recall names OEM since 2007.

Adverse event reports per year · OEM

1in 2023

2019: 12023: 1
2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code OEM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20111—00
20120—00
201333400
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20231—01
20240—00
20250—00
20260—0—

What is it indicated for?

The Quidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the qualitative detection and identification of respiratory syncytial virus and human metapneumovirus RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections in…

Read the full statement (121 words)

The Quidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the qualitative detection and identification of respiratory syncytial virus and human metapneumovirus RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.

Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Indications for use as stated in the FDA summary.

Also cleared against K092500

9 other devices cite the same predicate.

  • K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc. · 2016
  • K131813Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
  • K131728Quidel Molecular Influenza a + B AssayQuidel Corp. · 2013
  • K120413Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control PackFocus Diagnostics, Inc. · 20122 recalls
  • K113777Quidel Molecular Influenza a+BQuidel Corp. · 2012
  • K112172Quidel Molecular Influenza a + B AssayQuidel Corp. · 2011

More from Quidel Corp.

95 FDA decisions under this applicant name. See the company

  • K131813Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
  • K131728Quidel Molecular Influenza a + B AssayQuidel Corp. · 2013
  • K130398Sofia (R) RSV FiaQuidel Corp. · 2013
  • K131166Sofia (R) HCG FiaQuidel Corp. · 2013
  • K131606Sofia Influenza a+B FiaQuidel Corp. · 2013

Recent decisions in OEM

The OEM category page

  • K230349Lyra RSV+hMPV AssayQuidel Corporation · 2023
  • K132200Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013
  • K123838Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013
  • K112490Quidel Molecular HMPV AssayQuidel Corp. · 2011
  • K082688Pro HMPV+ AssayProdesse, Inc. · 2008

https://510kreport.com/device/K122189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122189: Quidel Molecular RSV + HMPV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122189

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