# K130650: Status DS Oxy

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Feb 26, 2014 after 352 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: 3 generations back to K014101 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060351: Medtox Oxycodone, Medtox Diagnostics, Inc. (2006) Summary page 1.

## Indications for use
The Status DSTM OXY is an immunocbromnatograhic test for the qualitative detection of Oxycodone in urine samples. The detection cut-off concentration of Oxycodone is 100 ng/mL. The test may be read visually or by using a DXpressm Reader. It is intended for clinical laboratory use only. This assay 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 the test reslt, particularly when preliminary positive results are obtained.

Source page: https://510kreport.com/device/K130650
Methodology: https://510kreport.com/methodology