Cleared Special

K032246 - MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM

K032246 is an FDA 510(k) clearance for MODIFICATION TO MULTITRANS CULTURE COLL..., manufactured by Starplex Scientific, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Special 510(k) pathway after a 22-day FDA review.

K032246 · Starplex Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K032246

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

JSM Device Classification - Class 1, General Controls

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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 109
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K032246.
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K032246 · MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
Download PDF FDA Summary Starplex Scientific, …