510(k) Report

510(k) · Cleared

Cleared

DASH Flu A/B Test

K261347510(k) Dual TrackCleared Oct 21, 2026180-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

Nuclein, LLC · OCC Respiratory Virus Panel Nucleic Acid Assay System

Cleared on Oct 21, 2026 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 21, 2026
Review
180 days
Class
Class II
Product code
OCC
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K261347Source: FDA 510(k) database · How lineage is built

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

Sources: FDA 510(k) 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 OCC? 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 OCC device

  1. #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All OCC devices

OCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · OCC

1in 2024

2008: 42009: 62010: 22011: 92012: 62013: 62014: 42015: 82016: 72017: 102018: 42019: 52020: 22021: 12022: 12023: 22024: 12026 (partial year): 3
2007high 10 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCC

31in 2019

2008: 28 days median2009: 24 days median2011: 82 days median2012: 125 days median2013: 79 days median2014: 94 days median2015: 85 days median2016: 92 days median2017: 136 days median2018: 134 days median2019: 31 days median2026 (partial year): 130 days median
2007high 136 (2017) · low 24 (2009)2026

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

Recalls per year · OCC

1in 2024

2014: 12018: 12019: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCC

2in 2025

2011: 22012: 12014: 522015: 12016: 362017: 12018: 12019: 22020: 172021: 6862022: 22023: 12024: 32025: 2
2007high 686 (2021) · low 0 (2007)2025

MAUDE reports naming product code OCC, 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
200842800
200962400
20102—00
201198202
2012612501
201367900
2014494152
201588501
2016792036
20171013601
2018413411
201953112
20202—017
20211—0686
20221—02
20232—01
20241—13
20250—02
202631300—

More from Nuclein, LLC

2 FDA decisions under this applicant name. See the company

  • K241652DASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC · 20243 recalls

Recent decisions in OCC

The OCC category page

  • K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc. · 2026
  • K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc. · 2026
  • K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc. · 2024
  • K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 20232 recalls
  • K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2023

https://510kreport.com/device/K261347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261347: DASH Flu A/B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261347

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Record history
  • FDA decision record loaded Nov 3, 2026
  • Page last updated Nov 3, 2026