# K200801: Quantisal Oral Fluid Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jul 28, 2020 after 123 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.
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)
- K183048: Quantisal II Oral Fluid Collection Device, Immunalysis Corporation (2019) Summary page 4.

## Most influential descendants
- K232898: Quantisal™ Oral Fluid Collection Device (2023), 0 descendants of its own

## Indications for use
For In Vitro Diagnostic Use The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol.

Source page: https://510kreport.com/device/K200801
Methodology: https://510kreport.com/methodology