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510(k) Data Aggregation
K Number
K200363Device Name
Quidel Triage® TOX Drug Screen, 94600
Manufacturer
Quidel Cardiovascular Inc.
Date Cleared
2020-03-11
(26 days)
Product Code
DKZ, DIS, DJG, DJR, JXM, JXO, LAF, LDJ, LFG
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Quidel Cardiovascular Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:
| Abbreviation | Analyte | Calibrator | Cutoff |
|--------------|---------------------------|-------------------------|------------|
| AMP | Amphetamines | d-Amphetamine | 500 ng/mL |
| mAMP | Methamphetamines | d-Methamphetamine | 500 ng/mL |
| BAR | Barbiturates | Butalbital | 200 ng/mL |
| BZO | Benzodiazepines | Temazepam | 200 ng/mL |
| COC | Cocaine | Benzoylecgonine | 150 ng/mL |
| EDDP | Methadone Metabolite | EDDP | 100 ng/mL |
| OPI | Opiates | Morphine | 300 ng/mL |
| THC | Cannabinoids | 11-nor-9-carboxy-Δ9-THC | 50 ng/mL |
| TCA | Tricyclic Antidepressants | Desipramine | 1000 ng/mL |
This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.
Device Description
The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.
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K Number
K182719Device Name
Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
Manufacturer
Quidel Cardiovascular Inc.
Date Cleared
2019-06-19
(264 days)
Product Code
DKZ, DIS, DJG, DJR, JXM, JXO, KHO, LAF, LDJ, LFG
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Quidel Cardiovascular Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:
| Abbreviation | Analyte | Calibrator | Cutoff |
|--------------|---------------------------|-------------------------|------------|
| AMP | Amphetamines | d-Amphetamine | 500 ng/mL |
| mAMP | Methamphetamines | d-Methamphetamine | 500 ng/mL |
| BAR | Barbiturates | Butalbital | 200 ng/mL |
| BZO | Benzodiazepines | Temazepam | 200 ng/mL |
| COC | Cocaine | Benzoylecgonine | 150 ng/mL |
| EDDP | Methadone Metabolite | EDDP | 100 ng/mL |
| OPI | Opiates | Morphine | 300 ng/mL |
| THC | Cannabinoids | 11-nor-9-carboxy-Δ9-THC | 50 ng/mL |
| TCA | Tricyclic Antidepressants | Desipramine | 1000 ng/mL |
This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.
Quidel Triage® MeterPro:
The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
Device Description
Quidel Triage® TOX Drug Screen, 94600:
The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.
Quidel Triage® MeterPro:
The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory or in a point-of-care setting.
The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.
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