Cleared Traditional

Quantisal? Oral Fluid Collection Device

K232898 · Immunalysis Corporation · Chemistry

Nov 2023

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K232898 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 November 21, 2023, 64 days after receiving the submission on September 18, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K232898 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2023
Decision Date	November 21, 2023
Days to Decision	64 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.