Cleared Traditional

K172412 - BacterioScan 216Dx System (FDA 510(k) Clearance)

Class I Microbiology device.

K172412 · Bacterioscan, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
264d
Days
Class 1
Risk

K172412 is an FDA 510(k) clearance for the BacterioScan 216Dx System. Classified as System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture (product code QBQ), Class I - General Controls.

Submitted by Bacterioscan, Inc. (Saint Louis, US). The FDA issued a Cleared decision on May 1, 2018 after a review of 264 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bacterioscan, Inc. devices

Submission Details

510(k) Number K172412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2017
Decision Date May 01, 2018
Days to Decision 264 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 102d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
Definition Qualitative, In Vitro Diagnostic System That Monitors Microbial Growth Directly From Normally Sterile Body Fluid Sample Incubated In A Liquid Culture Medium
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.