# K061617: Forsure One Step Dip & Read (X) Drug Screen Test

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Nov 22, 2006 after 166 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K004034 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050540: Ucp Rapid Drug Screening Tests, Ucp Biosciences, Inc. (2005) Summary page 2.
- K052882: Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device, Tianjin New Bay Bioresearch Co., Ltd. (2006) Summary page 2.

## Indications for use
Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels: Test Calibrator Cutoff Amphetamine D-Amphetamine 1000 ng/ml Methamphetamine D-Methamphetamine 1000 ng/ml Benzodiazepine Oxazepam 300 ng/ml Barbiturate Secobarbital 300 ng/ml Cocaine Benzoylecgonine 300 ng/ml Cannabinoids 1 1-nor-A9-THC-9 COOH 50 ng/ml Opiates Morphine 2000 ng/ml Phencyclidine Phencyclidine 25 ng/ml Methadone Methadone 300 ng/ml Oxycodone Oxycodone 100 ng/ml Tricyclic Antidepressant Nortriptyline 1000 ng/ml Propoxyphene Propoxyphene 300 ng/ml This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Source page: https://510kreport.com/device/K061617
Methodology: https://510kreport.com/methodology