Cleared Traditional

K212856 - iClean Viral Transport System (VTM-RT kit) (FDA 510(k) Clearance)

Class I Microbiology device.

K212856 · Huachenyang (Shenzhen) Technology Co. , Ltd. · Microbiology device
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Aug 2022
Decision
344d
Days
Class 1
Risk

K212856 is an FDA 510(k) clearance for the iClean Viral Transport System (VTM-RT kit). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Huachenyang (Shenzhen) Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2022 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Huachenyang (Shenzhen) Technology Co. , Ltd. devices

Submission Details

510(k) Number K212856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2021
Decision Date August 18, 2022
Days to Decision 344 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 102d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 110
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