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Oral-Eze Oral Fluid Collection System

by Osborn Laboratories, Inc. 510(k)

Active United States

510(k) K984361

Overview

The Oral-Eze Oral Fluid Collection System is an oral fluid drugs of abuse and alcohol test specimen collection device. It is intended for use by individuals under the supervision of trained professionals to collect, contain, and preserve oral-fluid specimens after collection and during transport from the collection area to the laboratory.

The device is supplied as a prescription device for use under supervision of a trained health care professional. It has received FDA 510(k) clearance (K984361) with product code PJD and is classified as a Class II device under regulation number 862.1675. The system is manufactured by Osborn Laboratories, Inc. and was granted substantial equivalence on January 13, 1999.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984361 Date13 Jan 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1101-2012 FDA Unclassified (pre-2012) initiated 7 Oct 2011 via K984361, on the same 510(k)

    Low buffer fill volumes on Oral-Eze, an oral fluid collection system.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
PJD
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Osborn Laboratories, Inc.

Questions

  • What is the Oral-Eze Oral Fluid Collection System used for?

    The Oral-Eze Oral Fluid Collection System is intended for use by individuals under the supervision of trained professionals to collect, contain, and preserve oral-fluid specimens after collection and during transport from the collection area to the laboratory for drugs of abuse and alcohol testing.

  • How is the Oral-Eze Oral Fluid Collection System supplied and who can use it?

    The device is supplied as a prescription device for use under the supervision of a trained health care professional, meaning it is not available for over-the-counter use and requires professional oversight during specimen collection.

  • Is the Oral-Eze Oral Fluid Collection System sterile and intended for single use?

    While the provided data does not explicitly state sterility or single-use status, the device is designed to collect, contain, and preserve specimens during transport, which implies it is intended for single-use application to maintain specimen integrity and prevent cross-contamination.

  • What regulatory pathway was used for the Oral-Eze Oral Fluid Collection System?

    The Oral-Eze Oral Fluid Collection System received FDA 510(k) clearance (K984361) on January 13, 1999, demonstrating substantial equivalence to a legally marketed predicate device under regulation number 862.1675 and product code PJD.