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510(k) Data Aggregation

    K Number
    K250803
    Device Name
    Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
    Manufacturer
    ANHUI Deepblue Medical Technological Co., Ltd.
    Date Cleared
    2025-04-15

    (29 days)

    Product Code
    NGL, NFT, NFV, NFW, NFY, NGG, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANHUI Deepblue Medical Technological Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, 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: Test | Calibrator | Cut-off(ng/mL) ---|---|--- 6-MAM | 6-Monoacetylmorphine | 10 AMP | d-Amphetamine | 500 or 1000 BAR | Secobarbital | 300 BUP | Buprenorphine | 10 BZO | Oxazepam | 300 COC | Benzoylecgonine | 150 or 300 EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 FYL | Fentanyl | 1 MDMA | Methylenedioxymethamphetamine | 500 MET | d-Methamphetamine | 500 or 1000 MTD | d/l-Methadone | 300 MOP/OPI | Morphine | 300 or 2000 OXY | Oxycodone | 100 PCP | Phencyclidine | 25 PPX | d-Propoxyphene | 300 TCA | Nortriptyline | 1000 THC | 11-nor-Δ9-THC-COOH | 50 The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. 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. The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs. Code | Substance | Cut-off(ng/mL) ---|---|--- AMP | Amphetamine | 1000 or 500 BUP | Buprenorphine | 10 BAR | Secobarbital | 300 BZO | Oxazepam | 300 COC | Cocaine | 300 or 150 EDDP | EDDP | 300 FYL | Fentanyl | 1 MET | Methamphetamine | 1000 or 500 MDMA | Ecstasy | 500 OPI | Morphine | 2000 or 300 MTD | Methadone | 300 OXY | Oxycodone | 100 PCP | Phencyclidine | 25 PPX | Propoxyphene | 300 TCA | Nortriptyline | 1000 THC | Marijuana | 50 6-MAM | 6-Monoacetylmorphine | 10 This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. 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
    Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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