Cleared Traditional

K211707 - BioTeke Sterile Disposable Virus Sampling Kit (FDA 510(k) Clearance)

Class I Microbiology device.

K211707 · Bioteke Corporation (Wuxi) Co., Ltd. · Microbiology device
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May 2022
Decision
335d
Days
Class 1
Risk

K211707 is an FDA 510(k) clearance for the BioTeke Sterile Disposable Virus Sampling Kit. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Bioteke Corporation (Wuxi) Co., Ltd. (Wuxi City, CN). The FDA issued a Cleared decision on May 4, 2022 after a review of 335 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 Bioteke Corporation (Wuxi) Co., Ltd. devices

Submission Details

510(k) Number K211707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2021
Decision Date May 04, 2022
Days to Decision 335 days
Submission Type Traditional
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
233d slower than avg
Panel avg: 102d · This submission: 335d
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 Consultant

QSR Consulting
Kenneth Kleinhenz

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

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