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510(k) Data Aggregation
K Number
K033454Device Name
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
2004-03-22
(144 days)
Product Code
JZO
Regulation Number
866.5870Why did this record match?
Applicant Name (Manufacturer) :
BRAHMS DIAGNOSTICA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUMItest TRAK human is a luminescence receptor assay (LRA) for the quantitative determination of antibodies against the human thyrotropin (TSH) receptor. The measurement of TSH receptor autoantibodies is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).
Device Description
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K Number
K021057Device Name
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
2002-09-17
(169 days)
Product Code
MSW
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
BRAHMS DIAGNOSTICA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DYNOtest Tg-pluS is a immunoradiometric assay (IRMA) for the quantitative determination of thyroglobulin in human serum. It is intended to aid in the monitoring for the presence of local or metastatic thyroid tissue in patients who have had thyroid gland ablation (by surgery with or without radioiodine therapy). DYNOtest Tg-pluS is also indicated for detecting the presence of thyroid tissue in patients with differentiated thyroid cancer when used with radioiodine whole body scans after recombinant thyrotropin (TSH) stimulation or thyroid hormone withdrawal. DYNOtest Tg-pluS includes a recovery test to aid in the detection of interfering anti-thyroglobulin antibodies or other substances.
Device Description
DYNOtest Tg-pluS is a two-step immunoradiometric assay for the quantitative determination of thyroglobulin in human serum using a coated tube technique. Two antigen specific antibodies that recognize different binding sites on the antigen (thyroglobulin) are used in excess. In the first step, thyroglobulin in the sample, standard or control binds to rabbit anti-human Tg polyclonal antibodies attached to the solid phase. Following incubation, unbound thyroglobulin and serum components are washed from the tube. In the second step, the radioactive tracer (mouse antihuman thyroglobulin monoclonal antibody) reacts with the bound antigen forming a sandwich complex fixed to the side of the tube. Following a second incubation, unreacted tracer is washed from the tube and remaining radioactivity in the tubes is measured. The measured radioactivity is directly proportional to the quantity of thyroglobulin in the sample, standard or control. The standard curve is used to derive the thyroglobulin concentration in the patients samples.
Recovery Test: Because non-specific interferents and anti-thyroglobulin antibodies can result in falsely low thyroglobulin values, DYNOtest Tg-pluS includes a recovery test, the purpose of which is to aid in the detection of such interferences. In the recovery test, recovery buffer containing a known quantity of thyroglobulin, is added to the patient sample. In parallel, the recovery buffer is added to a recovery reference sample (thyroglobulin free serum). The patient sample, recovery sample and recovery reference sample are all run using DYNOtest Tg-pluS. The percentage recovery is determined by subtracting the patient Tg value from the patient recovery sample and dividing this result by the recovery reference Tg value:
Recovery Tg - Patient Tg x 100 = % Recovery Recovery reference Tg
Recovery values between 70% and 130% are considered valid. Values <70% and >130% are due to interferences; these patient results should be considered invalid.
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K Number
K000286Device Name
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
2000-03-17
(46 days)
Product Code
JZO
Regulation Number
866.5870Why did this record match?
Applicant Name (Manufacturer) :
BRAHMS DIAGNOSTICA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000287Device Name
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
2000-03-17
(46 days)
Product Code
JZO
Regulation Number
866.5870Why did this record match?
Applicant Name (Manufacturer) :
BRAHMS DIAGNOSTICA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992790Device Name
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
1999-11-12
(85 days)
Product Code
JZO
Regulation Number
866.5870Why did this record match?
Applicant Name (Manufacturer) :
BRAHMS DIAGNOSTICA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DYNOtest anti-Tgn is a competitive radioimmunoassay (RIA) for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum using the coated tube technique. The DYNOtest anti-Tg, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
Device Description
DYNOtest anti-Tg, is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroglobulin in human sera using a coated tube technique. Human polyclonal antibodies against thyroglobulin bound to the solid phase compete with autoimmune antithyroglobulin antibodies in the sample for 1351 labeled thyroglobulin. Following incubation, unreacted labeled thyroglobulin is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroglobulin antibody in the sample.
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K Number
K992791Device Name
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
Manufacturer
BRAHMS DIAGNOSTICA, LLC.
Date Cleared
1999-11-12
(85 days)
Product Code
JZO
Regulation Number
866.5870Why did this record match?
Applicant Name (Manufacturer) :
BRAHMS DIAGNOSTICA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DYNOtest anti-TPOn is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
Device Description
DYNOtest anti-TPOn is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroid peroxidase in human sera using a coated tube technique. Monoclonal antibodies against thyroid peroxidase bound to the solid phase compete with autoimmune anti-thyroid peroxidase antibodies in the sample for indirectly 12-1 labeled thyroid peroxidase. Following incubation, unreacted indirectly labeled thyroid peroxidase and unreacted 1251 labeled antibody against TPO is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroid peroxidase antibody in the sample.
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