L-Cup

Basic Information

• Brand Name: L-Cup
• Primary DI: 00722066006757
• Version / Model: D12.11.1-1VLA
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-05
• Public Version: 2
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: efdd5c08-cc37-48c7-92ca-1ec7e523e2b2

Device Description

L-Cup Rapid Test w/ Adulteration (Urine). For the rapid detection of the following drugs in human urine: MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	862.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10722066006754	GS1		25	In Commercial Distribution
Primary	00722066006757	GS1
Package	20722066006751	GS1		100	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K182738	000