# K223497: Spectrum Saliva Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Solutions, LLC
- Decided: Feb 17, 2023 after 88 days
- Product code: QBD (Microbial Nucleic Acid Storage And Stabilization Device)
- Device class: 2
- Regulation: 21 CFR 866.2950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170029 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202641: DNA/RNA Shield Collection Tube, Zymo Research (2020) Summary page 4.

## Most influential descendants
- K240797: PPH Saliva Collection Kit (2024), 0 descendants of its own

## Indications for use
The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, inactivation, 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 devices. The device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.

Source page: https://510kreport.com/device/K223497
Methodology: https://510kreport.com/methodology