# K980836: Genie Cup Integrated Screening Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Technology Ventures, LLC
- Decided: Jun 29, 1998 after 117 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations. amphetamines 1000 ng/ml cocaine 300 ng/ml opiates 300 ng/ml phencyclidine (PCP) 25 ng/ml cannabinoids (THC) 50 ng/ml methamphetamines 500 ng/ml Genie Cup™ Integrated Screening Device 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 judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K980836
Methodology: https://510kreport.com/methodology