Cleared Traditional

Quantisal Oral Fluid Collection Device

K200801 · Immunalysis Corporation · Chemistry

Jul 2020

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K200801 is an FDA 510(k) clearance for the Quantisal 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, 2020, 123 days after receiving the submission on March 27, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K200801 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2020
Decision Date	July 28, 2020
Days to Decision	123 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.