Cleared Traditional

Spectrum Saliva Collection Device (K223497) - FDA 510(k) Clearance

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

K223497 · Spectrum Solutions, LLC · Microbiology device
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Feb 2023
Decision
88d
Days
Class 2
Risk

K223497 is an FDA 510(k) clearance for the Spectrum Saliva Collection Device. Classified as Microbial Nucleic Acid Storage And Stabilization Device (product code QBD), Class II - Special Controls.

Submitted by Spectrum Solutions, LLC (Draper, US). The FDA issued a Cleared decision on February 17, 2023 after a review of 88 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.

View all Spectrum Solutions, LLC devices

Submission Details

510(k) Number K223497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2022
Decision Date February 17, 2023
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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 K223497.
DNA/RNA Shield SafeCollect Saliva Collection kit
K231013 · Zymo Research · Sep 2023
CLEARinse CTS Specimen Collection and Transport System
K221664 · Aardvark Medical, Inc. · Jul 2023
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
K221802 · Mawi Dna Technologies · Apr 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Jan 2023
Dasky Disposable Sampling Tube (Model name: VSM02)
K211675 · Ningbo Dasky Life Science Co., Ltd. · Aug 2022
MagXtract Collection Tube
K212113 · Magbio Genomics, Inc. · Jul 2022