Premier Ehec

• • Terminated Z-1033-2017 FDA Class II ·initiated 8 Nov 2016

  Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

• • Terminated Z-0203-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011 ·on shared 510(k) K953362

  Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K953362 ↗

FDA Product Code

GNA

Device Class

Class I

Regulation

21 CFR Part 866.3255

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Blastomyces Dermatitidis Antigen (JWW)

  Class II

  FDA 510(k) K792680 Active Cleared 17 Jan 1980

• Candida Albicans, Antiserum

  Class II

  FDA 510(k) K792713 Active Cleared 23 Jan 1980

• Lacto-Phenol Analine Blue Fluid

  Class I

  FDA 510(k) K792703 Active Cleared 24 Jan 1980

• Immunocard Mycoplasma

  Class I

  FDA 510(k) K934550 Active Cleared 20 Sep 1994

• Histoplasma Capsulatum, Antiserum

  Class II

  FDA 510(k) K792718 Active Cleared 17 Jan 1980

• Blastomyces Dermatitidis, Antiserum

  Class II

  FDA 510(k) K792685 Active Cleared 17 Jan 1980

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