# K991751: Status Cup Accusign Cup

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jun 18, 1999 after 25 days
- Product code: DKE (Reagents, Test, Tetrahydrocannabinol)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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
Immunoassay for the qualitative detection of amphetamine, THC metabolites, cocaine metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows: AMP Amphetamine 1000 ng/mL THC 11-nor-A’-9-carboxylic acid 50 ng/mL COC Benzoylecgonine 300 ng/mL MET D-Methamphetamine 1000 ng/mL OPI Morphine 300 ng/mL PCP Phencyclidine 25 ng/mL

Source page: https://510kreport.com/device/K991751
Methodology: https://510kreport.com/methodology