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510(k) Data Aggregation
K Number
K230238Device Name
BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
Manufacturer
Shenzhen Bioeasy Biotechnology Co.,Ltd.
Date Cleared
2023-03-31
(60 days)
Product Code
DJG, NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Bioeasy Biotechnology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Marijuana (THC): 50 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Cannabinoids (THC): 50 ng/mL
6-Acetylmorphine: 10 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Device Description
The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The BIOEASY™ U-Catch MAX Multi-Drug Test Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
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K Number
K193480Device Name
BIOEASY Multi-Drug Test Cup
Manufacturer
Shenzhen Bioeasy Biotechnology Co.,Ltd.
Date Cleared
2020-01-31
(46 days)
Product Code
NGL, NFT, NFV, NFW, NFY, NGG, NGI, NGM, PTG, PTH, QAW, QBF
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Bioeasy Biotechnology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|--------------------------------|-------------------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
Device Description
The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
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K Number
K192515Device Name
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
Manufacturer
Shenzhen Bioeasy Biotechnology Co.,Ltd.
Date Cleared
2019-10-11
(28 days)
Product Code
LDJ
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Bioeasy Biotechnology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOEASY Marijuana Test Dip Card 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Dip Card 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Description
The BIOEASY Marijuana Test Dip Card and the BIOEASY Marijuana Test Strip tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch
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K Number
K192301Device Name
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
Manufacturer
Shenzhen Bioeasy Biotechnology Co.,Ltd.
Date Cleared
2019-09-20
(28 days)
Product Code
NFW
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Bioeasy Biotechnology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Description
The BIOEASY Marijuana Test Dip Card and the BIOEASY Marijuana Test Strip tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
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K Number
K182530Device Name
BIOEASY Multi-Drug Test Cup
Manufacturer
Shenzhen Bioeasy Biotechnology Co.,Ltd.
Date Cleared
2018-11-09
(56 days)
Product Code
NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW, QBF
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Bioeasy Biotechnology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|--------------------------------|---------------|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
Device Description
The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
Ask a Question
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