# K051958: MP Rapidoxy Test Strip, Model 07RD-7073

- Pathway: 510(k) (Traditional)
- Applicant: Mp Biomedicals, LLC
- Decided: Jul 21, 2006 after 367 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: 1 generation back to K033566 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033566: Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062, Rapid Diagnostics, Inc. (2004) Summary page 1.

## Most influential descendants
- K162395: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (2017), 0 descendants of its own

## Indications for use
The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-6-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml. The MP RapidBUP Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical onsideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml. The MP RapidOXY Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K051958
Methodology: https://510kreport.com/methodology