Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K032246
    Device Name
    MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
    Manufacturer
    STARPLEX SCIENTIFIC, INC.
    Date Cleared
    2003-08-13

    (22 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARPLEX SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Starswab Multitrans Collection and Transport System (Cat. No. S160) is intended for the collection and transportation of Chlamydia, Mycoplasmas and viruses obtained from clinical specimens.
    Device Description
    Starswab Multitrans Collection and Transport System provides a safe and convenient way to collect and transport clinical specimens without leakage under optimum storage conditions. The osmotically balanced buffered medium will maintain the viability of viral, chlamydia and mycoplasma specimens during transportation to the laboratory. Antibiotics are incorporated into the medium to inhibit growth of competing bacteria and yeast. The addition of serum albumin provides a stabilizing effect. The high concentration of sucrose aids in the preservation of viruses and chlamydia if the specimens are frozen (-70℃) for prolonged storage.
    Ask a Question
    K Number
    K022388
    Device Name
    STARTOX DRUG OF ABUSE SCREENING TEST (4)
    Manufacturer
    STARPLEX SCIENTIFIC, INC.
    Date Cleared
    2003-02-27

    (219 days)

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

    STARPLEX SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: | Compound | Abbreviation | Level | |---------------------------------------------------|--------------|------------| | Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml | | Opiates (morphine) | OPI | 300 ng/ml | | Cocaine (benzoylecgonine) | COC | 300 ng/ml | | Cannabinoids<br>(11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml | STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained. For professional use only.
    Device Description
    A lateral flow immunoassay for the detection of drugs of abuse.
    Ask a Question
    K Number
    K021006
    Device Name
    STARTOX DRUG OF ABUSE SCREENING TEST
    Manufacturer
    STARPLEX SCIENTIFIC, INC.
    Date Cleared
    2002-06-10

    (74 days)

    Product Code
    DKZ, DIO, DJG, LCM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARPLEX SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STARTOX™ Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOX™ is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: | Compound | Abbreviation | Level | |---------------------------------------------------|--------------|------------| | Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml | | Opiates (morphine-3-P-D glucuronide) | OPIATES | 2000 ng/ml | | Phencyclidine (phencyclidine HCl) | PCP | 25 ng/ml | | Cocaine (benzoylecgonine) | COCAINE | 300 ng/ml | | Cannabinoids<br>(11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml | STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained. For professional use only.
    Device Description
    A lateral flow immunoassay for the detection of drugs of abuse.
    Ask a Question
    K Number
    K962843
    Device Name
    MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
    Manufacturer
    STARPLEX SCIENTIFIC, INC.
    Date Cleared
    1996-09-18

    (58 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARPLEX SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960997
    Device Name
    STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
    Manufacturer
    STARPLEX SCIENTIFIC, INC.
    Date Cleared
    1996-04-03

    (22 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARPLEX SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Starswab Culture Collection and Transport System is selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory. The medium contains sodium thioglycollate as a reducing agent and the moisture and media depth provide an ideal environment for the survival of both aerobic and anaerobic microorganisms.
    Ask a Question

    Page 1 of 1