# K032057: Toxcup Drug Screen Cup Amp/Coc/Met/Opi/PCP/THC

- Pathway: 510(k) (Special)
- Applicant: Branan Medical Corp.
- Decided: Aug 21, 2003 after 50 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 18, 2020 · Class II · Z-3045-2020: 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.
- Mar 26, 2014 · Class II · Z-1508-2014: May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

## Indications for use
The ToxCupTMDrug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations: AMP — d-Amphetamine — 1000 ng/ml COC — Benzoylecgonine — 300 ng/ml MET500 — d-Methamphetamine — 500 ng/ml 0PI2000 — Morphine — 2000 ng/ml OPI300* — Morphine — 300ng/mI * PCP — Phencyclidine — 25 ng/ml THC — 11-nor-A9-Tetrahydrocannabinol-9-carboxylicacid — 50 ng/ml *The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 n g h . and the optional cut-off concentration indicated. The ToxCupTMDrug Screen Cup provides visual, qualitative results for multiple drugs-of-abused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Source page: https://510kreport.com/device/K032057
Methodology: https://510kreport.com/methodology