Captia(R) Syphilis M, Modification

• • Terminated Z-0819-2015 FDA Class III ·initiated 17 Nov 2014

  Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.

510(k) Number

K904524 ↗

FDA Product Code

LIP

FDA applicant

Mercia Diagnostics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Captia(R) Rubella-G

  Class II

  FDA 510(k) K883924 Active Cleared 15 Aug 1989

• Captia(R) Syphilis-G

  Class II

  FDA 510(k) K881425 Active Cleared 4 Aug 1988

• Modified Captia(R) Syphilis-M

  Class II

  FDA 510(k) K900654 Active Cleared 8 Mar 1990

• Captia(R) Toxo-M: an Enzyme Immunoassay

  Class II

  FDA 510(k) K871746 Active Cleared 31 Jul 1987

• Rotascreen

  Class I

  FDA 510(k) K872568 Active Cleared 14 Sep 1987

• Captia Toxo-G

  Class II

  FDA 510(k) K880918 Active Cleared 1 Aug 1988

See all devices from Mercia Diagnostics, Ltd. →