# K183048: Quantisal II Oral Fluid Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jul 29, 2019 after 269 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: 1 generation back to K942435 (1995). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942435: Saliva Sampler, Saliva Diagnostic Systems, Inc. (1995) Summary page 4.

## Most influential descendants
- K200801: Quantisal Oral Fluid Collection Device (2020), 1 descendant of its own
- K232898: Quantisal™ Oral Fluid Collection Device (2023), 0 descendants of its own
- K223781: Quantisal™ II Oral Fluid Collection Device (2023), 0 descendants of its own

## Indications for use
The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

Source page: https://510kreport.com/device/K183048
Methodology: https://510kreport.com/methodology