Cleared Traditional

K232454 - Viral Transport Media (VTM) (FDA 510(k) Clearance)

Class I Microbiology device.

K232454 · Alb Luz · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
263d
Days
Class 1
Risk

K232454 is an FDA 510(k) clearance for the Viral Transport Media (VTM). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Alb Luz (Valinhos, BR). The FDA issued a Cleared decision on May 3, 2024 after a review of 263 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Alb Luz devices

Submission Details

510(k) Number K232454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date May 03, 2024
Days to Decision 263 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
161d slower than avg
Panel avg: 102d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 110
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K232454.
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K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Aug 2024