# K011057: Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Jun 6, 2001 after 61 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE ElAs.

Source page: https://510kreport.com/device/K011057
Methodology: https://510kreport.com/methodology