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Found 30 results
510(k) Data Aggregation
K Number
K231832Device Name
Access Myoglobin
Manufacturer
Beckman Coulter, Inc
Date Cleared
2023-09-18
(88 days)
Product Code
DDR
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
Device Description
The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoglobin assay reagent pack, Access Myoglobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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K Number
K123785Device Name
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
Manufacturer
DIAZYME LABORATORIES
Date Cleared
2013-06-07
(179 days)
Product Code
DDR, JIT, JJX
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
Device Description
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
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K Number
K122599Device Name
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
Manufacturer
Siemens Healthcare Diagnostics Inc.
Date Cleared
2012-10-03
(37 days)
Product Code
DDR, JIT
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.
Device Description
The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
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K Number
K083260Device Name
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
Manufacturer
Roche Diagnostics
Date Cleared
2009-10-16
(345 days)
Product Code
DDR
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Device Description
The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
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K Number
K080481Device Name
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2009-02-20
(364 days)
Product Code
DDR, JIT
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
Device Description
The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
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K Number
K061683Device Name
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2006-07-21
(36 days)
Product Code
DDR, JIT
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
C.f.a.s. (Calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Device Description
The Tina-Quant® Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. In this immunoturbidimetric method, latex-bound anti-myoglobin antibodies react with antigen in the sample to form an antigen/antibody complex which after agglutination can be determined turbidimetrically. The calibrator is C.f.a.s. Myoglobin and the recommended control material is the Myoglobin Control Set.
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K Number
K042924Device Name
ARCHITECT STAT MYO IMMUNOASSAY
Manufacturer
FISHER DIAGNOSTICS
Date Cleared
2005-01-24
(94 days)
Product Code
DDR, JIS, MVE
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.
Device Description
The ARCHITECT® STAT Myoglobin assay is a two-step immunoassay for the quantitative determination of myoglobin in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-myoglobin coated paramagnetic microparticles are combined and incubated. Myoglobin present in the sample binds to the anti-myoglobin coated microparticles. After washing, antimyoglobin acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of myoglobin in the sample and the RLUs detected by the ARCHITECT® I* system optics.
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K Number
K042982Device Name
QUANTEX MYOGLOBIN
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2004-12-22
(54 days)
Product Code
DDR, JIT, JJX
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Ouantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
Device Description
Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Quantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
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K Number
K033300Device Name
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Date Cleared
2003-11-05
(22 days)
Product Code
DDR, JIS, JJX
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction.
For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin).
Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.
Device Description
The Vitros Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- 1. The Vitros Immunodiagnostic Products range of immunoassay products: Vitros Immunodiagnostic Products Myoglobin Reagent Pack, the Vitros Immunodiagnostic Products Myoglobin Calibrators and the Vitros Immunodiagnostic Products Myoglobin Range Verifiers, (which are combined by the Vitros Immunodiagnostic System to perform the Vitros Myoglobin assay), and Vitros Immunodiagnostic Products High Sample Diluent B.
- 2. The Vitros Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits.
- 3. Common reagents used by the Vitros System in each assay.
The Vitros System and common reagents are dedicated specifically for use only with the Vitros Immunodiagnostic Products range of immunoassay products.
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K Number
K021229Device Name
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2002-06-28
(71 days)
Product Code
DDR
Regulation Number
866.5680Why did this record match?
Product Code :
DDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
Device Description
The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
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