# K223781: Quantisal™ II Oral Fluid Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jul 28, 2023 after 224 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: 2 generations back to K942435 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183048: Quantisal II Oral Fluid Collection Device, Immunalysis Corporation (2019) Summary page 5.

## Indications for use
The Quantisal™ II 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/K223781
Methodology: https://510kreport.com/methodology