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510(k) Data Aggregation
K Number
K201494Device Name
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Manufacturer
Advin Biotech, Inc.
Date Cleared
2020-09-17
(104 days)
Product Code
DJG, DIO, DIS, DJC, DJR, DKZ, JXM, JXN, LCM, LDJ, LFG, NGG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Advin Biotech, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Calibrator | Cutoff (ng/mL) |
|------------------|----------------------------------------------------|----------------|
| 6-Acetylmorphine | 6-monoacetylmorphine | 10 |
| Amphetamine | d-Amphetamine | 500 |
| Amphetamine | d-Amphetamine | 1,000 |
| Secobarbital | Secobarbital | 300 |
| Oxazepam | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 10 |
| EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 |
| Cocaine | Benzoylecgonine | 150 |
| Cocaine | Benzoylecgonine | 300 |
| Ecstasy | d,l-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 1,000 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 20 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | d/l-Methadone | 300 |
| Opiates | Morphine | 300 |
| Opiates | Morphine | 2,000 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencyclidine | 25 |
| Propoxyphene | Propoxyphene | 300 |
| Nortriptyline | Nortriptyline | 1,000 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only.
The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Device Description
For prescription use, the devices consist of:
- a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests
- b. Package Insert
- c. Procedure Card
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K Number
K182123Device Name
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Manufacturer
Advin Biotech, Inc.
Date Cleared
2019-03-29
(235 days)
Product Code
DJG, DIO, DJC, DKZ
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Advin Biotech, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Ampletamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Calibrator | Cutoff (ng/mL) |
|---------------------------|----------------------------------------------------|----------------|
| 6-Acetylmorphine | 6-monoacetylmorphine | 10 |
| Amphetamine | d-Amphetamine | 500 |
| Amphetamine | d-Amphetamine | 1,000 |
| Barbiturates | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 10 |
| EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 |
| Cocaine | Benzoylecgonine | 150 |
| Cocaine | Benzoylecgonine | 300 |
| Ecstasy | d,l-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 1,000 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | d/l-Methadone | 300 |
| Opiates | Morphine | 300 |
| Opiates | Morphine | 2,000 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencyclidine | 25 |
| Propoxyphene | Propoxyphene | 300 |
| Tricyclic Antidepressants | Nortriptyline | 1,000 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only.
The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Device Description
For professional use, the devices consist of:
- a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests
- b. Package insert
- c. Procedure Card
Ask a Question
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