# K082508: Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corporation
- Decided: Nov 21, 2008 after 84 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 2 (0 Class I)
- 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) ACON® BUP One Step Buprenorphine Test Device: named in the summary without a submission number

## Recalls of this device
- Aug 18, 2020 · Class II · Z-3029-2020: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
- Aug 18, 2020 · Class II · Z-3030-2020: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

## Indications for use
The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are rapid immunochromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. The devices are intended for professional use only. They are not intended for over-the-counter sale to non-professionals. The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard tests are used to obtain visual, qualitative results. A more specific alternate method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS are the preferred confirmatory methods.

Source page: https://510kreport.com/device/K082508
Methodology: https://510kreport.com/methodology