Product Code: PJD FDA class 2 21 CFR 862.1675

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Clinical Chemistry

The Oral Fluid Drugs of Abuse and Alcohol Test Specimen Collection Device is used for the collection, preservation, and transport of oral fluid specimens for drugs of abuse and alcohol testing in clinical and forensic settings. It is an FDA Class 2 device regulated under 21 CFR 862.1675, requiring 510(k) premarket notification, within the Clinical Chemistry (CH) medical specialty. The product code is PJD. This device is not an implant and is not life-sustaining.

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Basic Information

Product Code: PJD
Device Class: FDA class 2
Regulation Number: 862.1675
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 9 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232898	Quantisal Oral Fluid Collection Device	Nov 21, 2023	Substantially Equivalent	Immunalysis Corporation
K223781	Quantisal II Oral Fluid Collection Device	Jul 28, 2023	Substantially Equivalent	Immunalysis Corporation
K200801	Quantisal Oral Fluid Collection Device	Jul 28, 2020	Substantially Equivalent	Immunalysis Corporation
K183048	Quantisal II Oral Fluid Collection Device	Jul 29, 2019	Substantially Equivalent	Immunalysis Corporation
K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX	Jun 06, 2001	Substantially Equivalent	OraSure Technologies, Inc.
K984361	ORAL-EZE ORAL FLUID COLLECTION SYSTEM	Jan 13, 1999	Substantially Equivalent	Osborn Laboratories, Inc.
K973395	EPISCREEN ORAL SPECIMEN COLLECTION DEVICE	Feb 13, 1998	Substantially Equivalent	Epitope, Inc.
K970357	EPISCREEN	Mar 10, 1997	Substantially Equivalent	Epitope, Inc.
K942435	SALIVA SAMPLER	Aug 21, 1995	Substantially Equivalent	Saliva Diagnostic Systems, Inc.