# K992068: Status Stik, Accusign Stik

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jul 6, 1999 after 18 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 or methamphetamine, opiates, cocaine metabolites, THC metabolites, and phencyclidine in human urine samples to assist in screening of drugs of abuse. The detecting cut-off concentrations are as follows: THC — 11-nor-Δ⁹-carboxylic acid — 50 ng/mL OPI — Morphine — 300 ng/mL COC — Benzoylecgonine — 300 ng/mL AMP — Amphetamine — 1000 ng/mL MET — D-Methamphetamine — 1000 ng/mL PCP — Phencyclidine — 25 ng/mL

Source page: https://510kreport.com/device/K992068
Methodology: https://510kreport.com/methodology