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510(k) Data Aggregation

    K Number
    K012390
    Device Name
    NO STEP ON SITE DEUG TEST CUP
    Date Cleared
    2001-12-18

    (144 days)

    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRUG FREE ENTERPRISES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Drug Free Enterprises NextStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine. The five test strips are individually encased within the wall of the device in separate chambers with no interconnections between each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The mine individual test strips include THC, cocaine, opiate, methamphesamine, pheneyclidine, amphesamine, barbiturates, benzodiazepines, and methadone. The cut-off concentration for each of the available test strip is listed below: | THC | 11-nor-A 9-THC-9-COOH | 50 | ng/ml | |-----|-----------------------|------|--------| | COC | Benzoylecogine | 300 | ng/ml | | OP' | Morphine | 2000 | ng/ml | | MET | Methamphetamines | 1000 | ng/ml | | PCP | Phencyclidine | 25 | ng/rnl | | AMP | Amphetamines | 1000 | ng/ml | | BAR | Secobarbital | 300 | ng/ml | | BZO | Oxazepam | 300 | ng/ml | | MTD | Methadone | 300 | ng/ml | Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine. The test is intended for professional and point of care use . This test device in not intended for over the counter sale to lay users. The NexStp test cup provides only preliminary analytical test results. A more specific atternate chemical method must be used in order to obtained a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
    Device Description
    Drug Free Enterprises NextStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine. The five test strips are individually encased within the wall of the device in separate chambers with no interconnections between each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The mine individual test strips include THC, cocaine, opiate, methamphesamine, pheneyclidine, amphesamine, barbiturates, benzodiazepines, and methadone.
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