Search Results
Found 1 results
510(k) Data Aggregation
K Number
K223497Device Name
Spectrum Saliva Collection Device
Manufacturer
Spectrum Solutions, LLC
Date Cleared
2023-02-17
(88 days)
Product Code
QBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
Spectrum Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.
Device Description
The Spectrum Solutions Saliva Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum's inactivating media. Sample collection is conducted under the supervision of a Health care provide. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.
Ask a Question
Page 1 of 1