Cleared Special

MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K032246) - FDA 510(k) Clearance

Class I Microbiology device.

K032246 · Starplex Scientific, Inc. · Microbiology device
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Aug 2003
Decision
22d
Days
Class 1
Risk

K032246 is an FDA 510(k) clearance for the MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Starplex Scientific, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on August 13, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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.

View all Starplex Scientific, Inc. devices

Submission Details

510(k) Number K032246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2003
Decision Date August 13, 2003
Days to Decision 22 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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.

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