Cleared Special

K032306 - VERSATREK

K032306 is an FDA 510(k) clearance for VERSATREK, manufactured by Trek Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code MDB cleared through the Special 510(k) pathway after a 28-day FDA review.

K032306 · Trek Diagnostic Systems, Inc. · Microbiology device
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Aug 2003
Decision
28d
Days
Class 1
Risk

K032306 is an FDA 510(k) clearance for the VERSATREK. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032306

510(k) Number K032306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date August 22, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MDB Device Classification - Class 1, General Controls

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
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.

Regulatory Peers - MDB System, Blood Culturing

All 67
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K032306.
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K021123 · bioMerieux, Inc. · Apr 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · bioMerieux, Inc. · Apr 2002
K032306 · VERSATREK
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