# K970357: Episcreen

- Pathway: 510(k) (Traditional)
- Applicant: Epitope, Inc.
- Decided: Mar 10, 1997 after 39 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Saliva Sampler: named in the summary without a submission number
- (no number) Salivette: named in the summary without a submission number
- (no number) Saliva Sac: named in the summary without a submission number

## Most influential descendants
- K973395: Episcreen Oral Specimen Collection Device (1998), 2 descendants of its own
- K984361: Oral-Eze Oral Fluid Collection System (1999), 1 descendant of its own
- K011057: Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX (2001), 0 descendants 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 'ransport - of oral fluid specimens’

Source page: https://510kreport.com/device/K970357
Methodology: https://510kreport.com/methodology