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510(k) K132726

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM by Primeradx — Product Code OZN

K132726 is an FDA 510(k) premarket notification submitted by Primeradx for the device "ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 2013. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2013
Date Received
August 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Toxin Gene Amplification Assay
Device Class
Class II
Regulation Number
866.3130
Review Panel
MI
Submission Type

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

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FDA data resources