# K020371: Uplink Test System

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Apr 3, 2002 after 58 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924446 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981341: STC Opiates Micro-Plate Eia (Orasure Application), OraSure Technologies, Inc. (1998) Summary page 1.

## Indications for use
The UPlink™ Oral Fluid Drug Test is a rapid immunoassay intended for use with the UP/ink™ Analyzer for the qualitative detection of opiates in oral fluid using a 40 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE. The UPlink™ Test System provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary, positive result is observed.

Source page: https://510kreport.com/device/K020371
Methodology: https://510kreport.com/methodology