# K052520: Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Apr 24, 2006 after 222 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.
- (no number) Gas chromatography/mass spectroscopy (GC/MS): named in the summary without a submission number

## Indications for use
Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezoylecgonine (BEG/COC), 11 -nor-A-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use. 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/K052520
Methodology: https://510kreport.com/methodology