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510(k) K153145

Lumipulse G TP-N Immunoreaction Cartridge Set by Fujirebio Diagnostics,Inc. — Product Code LIP

K153145 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "Lumipulse G TP-N Immunoreaction Cartridge Set". The FDA issued a decision of Substantially Equivalent on July 5, 2016. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2016
Date Received
October 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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)
  • DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40) (May 4, 2022)
  • 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)

Other clearances for product code LIP

  • K241427 — Access Syphilis (September 6, 2024)
  • K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack (August 28, 2024)
  • K211302 — Elecsys Syphilis (July 20, 2021)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K160910 — Elecsys Syphilis (July 28, 2016)
  • K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphi (June 15, 2016)
  • K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (March 14, 2012)
  • K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (January 20, 2012)
  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)
  • K102283 — ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (February 10, 2011)

FDA data resources