510(k) Report

De Novo · Granted

Granted

Norovirus Serological Reagent

DEN110001De NovoClass II21 CFR 866.3395

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

Unknown applicant · OUC Norovirus Serological Reagent

Granted as a new device type through De Novo. 16 later devices descend from it.

Class
Class II
Product code
OUC
Recalls
None

16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2016: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2015: 2 descendants cleared2017: 4 descendants cleared2020: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared
  1. This deviceDEN110001 Norovirus Serological Reagent ·
  2. Descendant · cites it directly · 15 of its ownK110968 Proflu+ AssayGen-Probe Prodesse, Inc. · 2011
  3. Descendant · 2 generations on · 13 of its ownK132129 Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013
  4. Descendant · 2 generations on · 5 of its ownK142045 Xpert Flu/RSV XC AssayCepheid · 2014
  5. Descendant · 2 generations on · 4 of its ownK153544 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas…Iquum, Inc. · 2016
  6. Descendant · 3 generations on · 4 of its ownK151226 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2015

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 12014: 12015: 22016: 12017: 42018: 12020: 12021: 12022: 12026: 1
2011high 4 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 16 · See all
  • K110968Proflu+ AssayGen-Probe Prodesse, Inc. · 2011 · cites it directly15descendants
  • K132129Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013 · 2 generations on13descendants
  • K142045Xpert Flu/RSV XC AssayCepheid · 2014 · 2 generations on5descendants
  • K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc. · 2016 · 2 generations on4descendants
  • K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid · 2015 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN110001Norovirus Serological Reagent—
+1K110968Proflu+ AssayGen-Probe Prodesse, Inc.2011—
+2K132129Prodesse Proflu+ AssayGen-Probe Prodesse, Inc.2013—
+2K142045Xpert Flu/RSV XC AssayCepheid2014—
+2K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.2016—
+3K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert…Cepheid2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201310
201410
201520
201610
201740
201810
202010
202110
202210
202610
FIG. 1 — Lineage of DEN110001, –2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Planning a device in OUC? 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
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Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110968Proflu+ AssayGen-Probe Prodesse, Inc.201115

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?

  • Of its descendants, K110968 (Gen-Probe Prodesse, Inc., 2011) has gone furthest, with 15 descendants of its own.

https://510kreport.com/device/DEN110001 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN110001: Norovirus Serological Reagent.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN110001

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026