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510(k) DEN200072

Lumipulse G ß-Amyloid Ratio (1-42/1-40) by Fujirebio Diagnostics,Inc. — Product Code QSE

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 4, 2022
Date Received
November 20, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alzheimer’S Disease Pathology Assessment Test
Device Class
Class II
Regulation Number
866.5840
Review Panel
IM
Submission Type

In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.

Other clearances by Fujirebio Diagnostics,Inc.

  • K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 (December 16, 2025)
  • K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (May 16, 2025)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K200997 — Lumipulse G CA19-9-N (May 14, 2020)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)

Other clearances for product code QSE

  • K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (June 5, 2023)
  • K221842 — Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (December 7, 2022)