PJD · Class II · 21 CFR 862.1675

FDA Product Code PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing.

Leading manufacturers include Immunalysis Corporation, Epitope, Inc. and Osborn Laboratories, Inc..

9
Total
9
Cleared
161d
Avg days
1995
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device Devices (Product Code PJD)

9 devices
1–9 of 9
Cleared Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
K232898
Immunalysis Corporation
Chemistry · 64d
Cleared Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
K223781
Immunalysis Corporation
Chemistry · 224d
Cleared Jul 28, 2020
Quantisal Oral Fluid Collection Device
K200801
Immunalysis Corporation
Chemistry · 123d
Cleared Jul 29, 2019
Quantisal II Oral Fluid Collection Device
K183048
Immunalysis Corporation
Chemistry · 269d
Cleared Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057
OraSure Technologies, Inc.
Toxicology · 61d
Cleared Jan 13, 1999
ORAL-EZE ORAL FLUID COLLECTION SYSTEM
K984361
Osborn Laboratories, Inc.
Chemistry · 37d
Cleared Feb 13, 1998
EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
K973395
Epitope, Inc.
Chemistry · 176d
Cleared Mar 10, 1997
EPISCREEN
K970357
Epitope, Inc.
Microbiology · 39d

About Product Code PJD - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code PJD since 1995, with 9 receiving FDA clearance (average review time: 161 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.