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Found 15 results
510(k) Data Aggregation
K Number
K142262Device Name
AUTION CHECK PLUS
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2015-04-10
(239 days)
Product Code
JJW
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
Device Description
The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.
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K Number
K113177Device Name
COMPLETE D 25-OH VITAMIN D CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2012-05-10
(195 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Complete D® 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.
Device Description
This quality control product is intended to allow an objective measurement of a laboratories performance (procedures and personnel techniques) in comparison to known values. Two clinically relevant levels of controls are available to compare observations with expected ranges therefore assuring consistent performance.
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K Number
K103744Device Name
DROPPER A1C DIABETES CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2011-05-12
(140 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.
Device Description
Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.
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K Number
K062942Device Name
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2006-10-30
(32 days)
Product Code
LAS
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Device Description
Not Found
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K Number
K062751Device Name
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2006-10-03
(19 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Device Description
Not Found
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K Number
K060417Device Name
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2006-03-21
(32 days)
Product Code
DIF
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.
Device Description
Not Found
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K Number
K032791Device Name
GLYCOHEMOSURE HBA1C CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2003-10-30
(52 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.
Device Description
The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.
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K Number
K030826Device Name
PRECISET DAT AMPHETAMINE
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2003-04-03
(20 days)
Product Code
DIJ
Regulation Number
862.3550Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
Device Description
The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.
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K Number
K021393Device Name
PRECISET DAT PLUS
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2002-06-13
(42 days)
Product Code
DKB
Regulation Number
862.3200Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Device Description
The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids. Drug concentrations are determined using GC/MS.
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K Number
K013662Device Name
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2002-03-08
(122 days)
Product Code
JHO
Regulation Number
862.1475Why did this record match?
Applicant Name (Manufacturer) :
QUANTIMETRIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.
Device Description
Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions. The software application is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and generate characterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, LDL, HDL).
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