Cleared Traditional

K231013 - DNA/RNA Shield SafeCollect Saliva Collection kit (FDA 510(k) Clearance)

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

K231013 · Zymo Research · Microbiology device
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Sep 2023
Decision
171d
Days
Class 2
Risk

K231013 is an FDA 510(k) clearance for the DNA/RNA Shield SafeCollect Saliva Collection kit. Classified as Microbial Nucleic Acid Storage And Stabilization Device (product code QBD), Class II - Special Controls.

Submitted by Zymo Research (Irvine, US). The FDA issued a Cleared decision on September 28, 2023 after a review of 171 days - an extended review 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: 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 Zymo Research devices

Submission Details

510(k) Number K231013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2023
Decision Date September 28, 2023
Days to Decision 171 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
69d slower than avg
Panel avg: 102d · This submission: 171d
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 K231013.
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