# K232898: Quantisal™ Oral Fluid Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Nov 21, 2023 after 64 days
- Product code: PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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 K942435 (1995). 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)
- K200801: Quantisal Oral Fluid Collection Device, Immunalysis Corporation (2020) Summary page 5.

## Indications for use
The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.

Source page: https://510kreport.com/device/K232898
Methodology: https://510kreport.com/methodology