Great News - VivaChek Receives FDA 510(k) Clearance For Multi-Drug Urine Test Cup
November 10, 2022
VivaChek received FDA 510(k) clearance for its Multi-Drug Urine Test Cup which aims to provide an accurate and less invasive way for drug testing. A 510(k) is a premarketing submission made to U.S. Food and Drug Administration and the clearance demonstrates that the device to be marketed is as safe and effective.
According to the UNDCP estimation of the world drug abuse, there are 218 million people affected by drug abuse in the world, among them 29 million suffer from drug-use caused disorders. However, only one out of every six people with a drug-use caused disorder receives proper treatment [1]. Data the from National Vital Statistics System shows that in 2021, there were 106,699 drug overdose deaths, resulting in an age-adjusted rate of 32.4 per 100,000 in the United States[2].
Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of some the most popular drugs including, Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. The cutoff concentrations of each drug as:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP300) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Opiate (OPI2000) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Reference:
1. Merianne Rose Spencer, M.P.H., Arialdi M. Miniño, M.P.H., and Margaret Warner, Ph.D. Drug Overdose Deaths in the United States, 2001–2021.
2. https://www.cdc.gov/nchs/nvss/drug-overdose-deaths.htm#find-our-data