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510(k) Data Aggregation
K Number
K000661Device Name
RANDOX PREALBUMIN
Manufacturer
RANDOX LABORATORIES, LTD.
Date Cleared
2000-04-13
(45 days)
Product Code
JZJ
Regulation Number
866.5060Why did this record match?
Product Code :
JZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972638Device Name
TINA-QUANT PREALBUMIN
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1998-01-09
(178 days)
Product Code
JZJ
Regulation Number
866.5060Why did this record match?
Product Code :
JZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoturbidometric assay for the quantitative in-vitro determination of Prealbumin.
Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma.
Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
Device Description
The Prealbumin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Prealbumin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Prealbumin antibodies (R₂ reagent) is added to mixture of the first step. The antibody binds to the Prealbumin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of Prealbumin present in the sample.
The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Prealbumin in the sample is directly proportional to the amount of turbidity formed.
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