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510(k) K140455

CAPTIA MEASLES IGM by Trinity Biotech USA — Product Code PCL

K140455 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "CAPTIA MEASLES IGM". The FDA issued a decision of Substantially Equivalent on May 22, 2014. The device falls under product code PCL (Enzyme Linked Immunoabsorbent Assay, Rubeola Igm), a Class I device regulated under 21 CFR 866.3520. Trinity Biotech USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2014
Date Received
February 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

The qualitative detection of measles specific IgM antibodies in serum or plasma.

Other clearances by Trinity Biotech USA

  • K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033064 — MYCOPLASMA IGG (November 26, 2003)
  • K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033067 — PYLORI IGG (November 26, 2003)
  • K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K993839 — ENA PROFILE ELISA TEST SYSTEM (January 12, 2000)
  • K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT (November 26, 1999)

FDA data resources