510(k) Report

FDA applicant

Fujirebio Diagnostics,Inc.

Malvern, PA45 decisions1989–202514 recalls

FDA records 45 decisions for Fujirebio Diagnostics,Inc. (Malvern, PA) from 1989 to 2025: 44 510(k) clearances and 1 De Novo grant. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JIT (Calibrator, Secondary). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 12 of them its own earlier devices. 14 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, clinical chemistry panel, where it files most

How often FDA has decided Fujirebio Diagnostics,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 22008: 22009: 12010: 32011: 62013: 12014: 22015: 22016: 52017: 62019: 12020: 32022: 12025: 2
2007high 6 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

7in 2025

2010: 22011: 12012: 12019: 32025: 7
2007high 7 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Fujirebio Diagnostics,Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fujirebio Diagnostics,Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)7decisions
  • JITCalibrator, Secondary5decisions
  • OIUTest, Epithelial Ovarian Tumor Associated Antigen (He4)4decisions
  • NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic…4decisions
  • ONXOvarian Adnexal Mass Assessment Score Test System3decisions
  • OVKCytokeratin Fragments 21-1 Eia Kit2decisions

Also: NBC (2), LTK (2), MOI (2), CEW (1), OSX (1), JFT (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 4 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 41 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 12 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.

  • K020566Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc. · 20025cite it
  • DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 20224cite it
  • K070820Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 20074cite it
  • K072939HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 20083cite it
  • K103358Roma (HE4 Eia + Architect CA 125 II)Fujirebio Diagnostics,Inc. · 20113cite it
  • K100831Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc. · 20112cite it

What has FDA decided for it lately?

  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20257 recalls
  • DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
  • K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020
  • K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020
  • K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc. · 2020
  • K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019
  • K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc. · 2017

All 45 as Fujirebio Diagnostics,Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K242706Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number…Dec 11, 2025Class II
  • K242706Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software…Dec 11, 2025Class II
  • K242706Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog…Dec 11, 2025Class II
  • K242706Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number…Dec 11, 2025Class II
  • K242706Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557…Dec 11, 2025Class II
  • K242706Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges…Dec 11, 2025Class II

Other applicant names beginning “Fujirebio”

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

Fujirebio Diagnostics Texas, Inc. 2Fujirebio America, Inc. 2Fujirebio Europe N.V. 1Fujirebio Dianostics, Inc. 1