Cleared Traditional

Quantisal II Oral Fluid Collection Device

K183048 · Immunalysis Corporation · Chemistry

Jul 2019

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K183048 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 29, 2019, 269 days after receiving the submission on November 2, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K183048 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2018
Decision Date	July 29, 2019
Days to Decision	269 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.