# K030113: Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen Dipstick Test, Model MD23

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corp.
- Decided: Jul 2, 2003 after 170 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 1 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 18, 2020 · Class II · Z-3034-2020: 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 Monitect@ Oxycodone Drug Screen Cassette Test and FastectTM Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect@ Oxycodone Drug Screen Casette Test and FastectTM Oxycodone Drug Screen Dipstick Test are used to obtain visu:sl, qualitative results. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatographymass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users.

Source page: https://510kreport.com/device/K030113
Methodology: https://510kreport.com/methodology