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510(k) Data Aggregation

    K Number
    K060355
    Device Name
    ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-08-07

    (175 days)

    Product Code
    DJC
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL.
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    K Number
    K060354
    Device Name
    ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-07-28

    (165 days)

    Product Code
    JXM
    Regulation Number
    862.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual, qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    Not Found
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    K Number
    K053037
    Device Name
    ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-06-15

    (231 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    A lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine.
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    K Number
    K053033
    Device Name
    ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-06-06

    (222 days)

    Product Code
    DJC
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL.
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    K Number
    K053034
    Device Name
    ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-06-06

    (222 days)

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

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL
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    K Number
    K053035
    Device Name
    ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-05-05

    (190 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) anchiate is preferred.
    Device Description
    Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL
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    K Number
    K060353
    Device Name
    ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-05-03

    (79 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL.
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    K Number
    K053032
    Device Name
    ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000
    Manufacturer
    ACRO BIOTECH LLC.
    Date Cleared
    2006-02-09

    (105 days)

    Product Code
    DKZ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRO BIOTECH LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
    Device Description
    Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.
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