Product code PJD— Clinical Chemistry
EPISCREEN
- Classification name
- Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.”
Market context for product code PJD
FDA has cleared devices under product code PJD between 1995 and 2023, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2020
- 2019
- 2001
- 1999
- 1998
- 1997
- 1995
Top applicants under product code PJD
Recent clearances under product code PJD
- K232898 — Quantisal Oral Fluid Collection Device
- K223781 — Quantisal II Oral Fluid Collection Device
- K200801 — Quantisal Oral Fluid Collection Device
- K183048 — Quantisal II Oral Fluid Collection Device
- K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
- K984361 — ORAL-EZE ORAL FLUID COLLECTION SYSTEM
- K973395 — EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
- K970357 — EPISCREEN
- K942435 — SALIVA SAMPLER
Data sourced from openFDA. This site is unofficial and independent of the FDA.