Cleared Traditional

K232454 - Viral Transport Media (VTM)

K232454 is an FDA 510(k) clearance for Viral Transport Media (VTM), manufactured by Alb Luz. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K232454 · Alb Luz · Microbiology device
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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

FDA 510(k) Submission Details - K232454

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.

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 58
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K232454.
OmniTrans Transport System
K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Aug 2024
Viral Transport Medium
K233534 · Hardy Diagnostics · Aug 2024
Avantik VTM
K233449 · Hanchang Medic Co., Ltd. (Han Chang Medic) · Jul 2024
Copan Universal Transport Medium (UTM-RT) System
K232357 · Copan Italia Spa · Apr 2024
Azer Scientific Universal Transport Medium
K202531 · Azer Scientific, Inc. · Apr 2024
ARX Viral Transport Media Collection and Transport System
K231843 · Arx Sciences, Inc. · Mar 2024