# K043051: Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech, Inc.
- Decided: Feb 7, 2005 after 95 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
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. The FDA summary names its predicate without a number.
- (no number) ABMC RapidOne Oxycodone test: named in the summary without a submission number

## Indications for use
The QuickScreen TM Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL. This test is intended for professional use. This test provides only a preliminary test result A more specific alternate testing method must be used in order to obtain a confirmed analytical result Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

Source page: https://510kreport.com/device/K043051
Methodology: https://510kreport.com/methodology