Cleared Traditional

Quantisal? II Oral Fluid Collection Device

K223781 · Immunalysis Corporation · Chemistry

Jul 2023

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K223781 is an FDA 510(k) clearance for the Quantisal? II Oral Fluid Collection Device, a Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (Class II — Special Controls, product code PJD), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on July 28, 2023, 224 days after receiving the submission on December 16, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K223781 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2022
Decision Date	July 28, 2023
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PJD — Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1675
Definition	Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing.