Cleared Traditional

INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX

K011057 · OraSure Technologies, Inc. · Toxicology

Jun 2001

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K011057 is an FDA 510(k) clearance for the INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX, a Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (Class II — Special Controls, product code PJD), submitted by OraSure Technologies, Inc. (Bethelehem, US). The FDA issued a Cleared decision on June 6, 2001, 61 days after receiving the submission on April 6, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K011057 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2001
Decision Date	June 06, 2001
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
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.