# K071489: Homecheck Multiple Drug Cup Test

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Mar 28, 2008 after 303 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine. 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. HPLC is preferred confirmatory method for Tricyclic Antidepressant.

Source page: https://510kreport.com/device/K071489
Methodology: https://510kreport.com/methodology