Cleared Traditional

K201849 - eNAT molecular collection and preservation medium (FDA 510(k) Clearance)

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

K201849 · Copan Italia Spa · Microbiology device
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Sep 2020
Decision
73d
Days
Class 2
Risk

K201849 is an FDA 510(k) clearance for the eNAT molecular collection and preservation medium. Classified as Microbial Nucleic Acid Storage And Stabilization Device (product code QBD), Class II - Special Controls.

Submitted by Copan Italia Spa (Brescia, IT). The FDA issued a Cleared decision on September 17, 2020 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K201849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2020
Decision Date September 17, 2020
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
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
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