Search Results
Found 1 results
510(k) Data Aggregation
K Number
K981592Device Name
ACS:CENTAUR AFP
Manufacturer
CHIRON DIAGNOSTICS CORP.
Date Cleared
1998-07-07
(64 days)
Product Code
LOQ
Regulation Number
866.6010Why did this record match?
Product Code :
LOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:
- human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, * as an aid in detecting open neural defects (NTD) when used in conjunction with ultrasonography and amniography testing,
- human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.
Device Description
The Chiron Diagnostics ACS:Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.
Ask a Question
Page 1 of 1