# K240797: PPH Saliva Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Permantis Public Health
- Decided: Oct 11, 2024 after 203 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: 3 generations back to DEN170029 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223497: Spectrum Saliva Collection Device, Spectrum Solutions, LLC (2023) Summary page 7.

## Indications for use
The PPH Saliva Collection Kit 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 device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K240797
Methodology: https://510kreport.com/methodology