# K100951: Medtox Buprenorphine Test

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Oct 18, 2010 after 195 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 K060466 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060466: Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device, ACON Laboratories, Inc. (2006) Summary page 1.

## Indications for use
The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is intended for prescription use only. The MEDTOX Buprenorphine Test is not for over-the-counter sale. It is not intended for use in point-of-care settings. MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations: BUP Buprenorphine (Buprenorphine) 10 ng/mL The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result.

Source page: https://510kreport.com/device/K100951
Methodology: https://510kreport.com/methodology