510(k) Report

FDA applicant

Diasorin Molecular, LLC

Cypress, CA14 decisions2018–20263 recalls

FDA records 14 decisions for Diasorin Molecular, LLC (Cypress, CA) from 2018 to 2026: 13 510(k) clearances and 1 De Novo grant. Most are in product codes QOF (Multi-Target Respiratory Specimen Nucleic Acid…) and OZZ (Bordetella Pertussis Dna Assay System). Since 2016 its 510(k)s took a median of 179 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Diasorin Molecular, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2018: 42019: 22020: 12022: 22023: 12024: 12025: 22026 (partial year): 1
2018high 4 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2023

2020: 22023: 1
2018high 2 (2020) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Diasorin Molecular, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other…3decisions
  • OZZBordetella Pertussis Dna Assay System2decisions
  • PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous…2decisions
  • PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System1decision
  • QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital…1decision
  • QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test1decision

Also: NJR (1), OCC (1), SBT (1), PGX (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 179 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 178 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220963Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC · 20232cite it
  • K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 20181cites it

What has FDA decided for it lately?

  • K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLC · 2026
  • K251978Liaison Nes Flu a/B, RSV & Covid-19Diasorin Molecular, LLC · 2025
  • K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack…Diasorin Molecular, LLC · 2025
  • DEN230092Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit…Diasorin Molecular, LLC · 2024
  • K220963Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC · 2023
  • K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackDiasorin Molecular, LLC · 2022
  • K212147Simplexa COVID-19 DirectDiasorin Molecular, LLC · 2022
  • K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackDiasorin Molecular, LLC · 20201 recall

All 14 as Diasorin Molecular, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K201505Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656…Jan 30, 2023Class II
  • K190219MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX…May 12, 2020Class II
  • K192376MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX…May 12, 2020Class II

Other applicant names beginning “Diasorin”

FDA records each applicant name separately; these may or may not be the same firm.

DiaSorin, Inc. 97Diasorin/American Standard Companies 1