Cleared Traditional

Biosci™ Inactivated Transport Medium, Biosci™ ITM (K220059) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220059 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Microbiology device
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Jan 2023
Decision
374d
Days
Class 2
Risk

K220059 is an FDA 510(k) clearance for the Biosci™ Inactivated Transport Medium, Biosci™ ITM. Classified as Microbial Nucleic Acid Storage And Stabilization Device (product code QBD), Class II - Special Controls.

Submitted by Shenzhen Dakewe Bio-Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 19, 2023 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2950 - 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 Shenzhen Dakewe Bio-Engineering Co., Ltd. devices

Submission Details

510(k) Number K220059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2022
Decision Date January 19, 2023
Days to Decision 374 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
272d slower than avg
Panel avg: 102d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBD Microbial Nucleic Acid Storage And Stabilization Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2950
Definition Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QBD Microbial Nucleic Acid Storage And Stabilization Device

All 16
Devices cleared under the same product code (QBD) and FDA review panel - the closest regulatory comparables to K220059.
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