# K013124: Modification to Scooper Drug/Adulteration Test Cup

- Pathway: 510(k) (Special)
- Applicant: Branan Medical Corp.
- Decided: Nov 7, 2001 after 49 days
- Product code: DJJ (Fluorometry, Morphine)
- Device class: 2
- Regulation: 21 CFR 862.3640
- Recalls of this device: none
- 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.

## Indications for use
The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection of morphine, amphetamines, THC, cocaine and phencyclidine in human urine. The cutoff concentrations are as follows: OPI Morphine 2000 ng/ml AMP Amphetamines 1000 ng/ml THC 11-nor-A’-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml CcocC Benzoylecgonine 300 ng/ml PCP Phencyclidine 25 ng/ml The ScooperTM Drug/Adulteration Test Cup is used to obtain visual, qualitative results and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.

Source page: https://510kreport.com/device/K013124
Methodology: https://510kreport.com/methodology