# K973395: Episcreen Oral Specimen Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Epitope, Inc.
- Decided: Feb 13, 1998 after 176 days
- Product code: PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970357 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970357: Episcreen, Epitope, Inc. (1997) Summary page 2.

## Most influential descendants
- K984361: Oral-Eze Oral Fluid Collection System (1999), 1 descendant of its own
- K991800: Hemochek Urine Collection Kit (1999), 0 descendants of its own

## Indications for use
EpiScreen is intended for use in the collection, preservation, and transport of oral specimens.

Source page: https://510kreport.com/device/K973395
Methodology: https://510kreport.com/methodology