Cleared Traditional

PanNAT STEC Test

K173330 · Micronics, Inc. · Microbiology
Jun 2018
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K173330 is an FDA 510(k) clearance for the PanNAT STEC Test, a Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCI), submitted by Micronics, Inc. (Redmond, US). The FDA issued a Cleared decision on June 1, 2018, 221 days after receiving the submission on October 23, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number K173330 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2017
Decision Date June 01, 2018
Days to Decision 221 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PCI — Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3990
Definition A Gastrointestinal Bacterial Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Bacterial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Bacterial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.

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