Cleared Traditional

IMDX C.DIFFICILE FOR ABBOTT M2000

K132235 · Intelligent Medical Devices, Inc. · Microbiology

Oct 2013

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K132235 is an FDA 510(k) clearance for the IMDX C.DIFFICILE FOR ABBOTT M2000, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Intelligent Medical Devices, Inc. (Beverly, US). The FDA issued a Cleared decision on October 11, 2013, 85 days after receiving the submission on July 18, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K132235 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2013
Decision Date	October 11, 2013
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3130
Definition	Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.