# K042990: For Sure One Step Buprenorphine Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: May 10, 2005 after 193 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: 2 generations back to K001178 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040316: Cedia Buprenorphine Assay, Microgenics Corp. (2004) Summary page 1.
- (no number) GC/MS: named in the summary without a submission number

## Most influential descendants
- K122064: Forsure One Step Buprenorphine Cup Test Device (2013), 0 descendants of its own

## Indications for use
For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test results particularly when preliminary results are used.

Source page: https://510kreport.com/device/K042990
Methodology: https://510kreport.com/methodology