# K052882: Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Feb 15, 2006 after 126 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: 1 generation back to K004034 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004034: Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12, Branan Medical Corp. (2001) Summary page 2.
- K022915: Instant-View Propoxyphene (PPX) Urine Test, Alfa Scientific Designs, Inc. (2002) Summary page 2.

## Most influential descendants
- K071489: Homecheck Multiple Drug Cup Test (2008), 0 descendants of its own
- K061617: Forsure One Step Dip & Read (X) Drug Screen Test (2006), 0 descendants of its own

## Indications for use
Forsure Rapid One Step Single or Multiple(X) Abuse Drug Screen Test Cup Device for Detection of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Cannabinoid, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates, Propoxyphene and their metabolites in human urine at the following concentrations: The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /Mass spectrometry (GC/MS) is the preferred confirmatory method. The testing and results are intended to be used by medical professional and clinical setting.

Source page: https://510kreport.com/device/K052882
Methodology: https://510kreport.com/methodology