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510(k) K014233

CAPTIAM SYPHILIS-G ASSAY by Trinity Biotech, Plc — Product Code LIP

K014233 is an FDA 510(k) premarket notification submitted by Trinity Biotech, Plc for the device "CAPTIAM SYPHILIS-G ASSAY". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Trinity Biotech, Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
December 26, 2001
Clearance Type
Special
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 Trinity Biotech, Plc

  • K172254 — Lyme B. burgdorferi (IgM) MarStripe Test (October 23, 2017)
  • K163095 — Lyme B. burgdorferi (IgG) MarStripe Test (February 1, 2017)
  • K120001 — UNIGOLD GIARDIA (March 1, 2013)
  • K121565 — UNI-GOLD CRYPTOSPORIDIUM (February 8, 2013)
  • K083896 — DESTINY MAX COAGULATION ANALYZER (July 2, 2009)
  • K033059 — HERPES GROUP IGG (November 26, 2003)
  • K011709 — UNI-GOLD STREP A TEST KIT (November 8, 2001)
  • K001525 — CAPTIA SYPHILIS-G ELISA TEST SYSTEM (November 29, 2000)
  • K991697 — UNI-GOLD H. PYLORI (December 21, 1999)
  • K982373 — UNI-GOLD STREP A TEST KIT (February 11, 1999)

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)
  • K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set (July 5, 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)

FDA data resources