Search Results
Found 3 results
510(k) Data Aggregation
K Number
K191718Device Name
Buhlmann fCAL turbo and CALEX Cap
Manufacturer
BUHLMANN Laboratories AG
Date Cleared
2019-09-24
(90 days)
Product Code
NXO
Regulation Number
866.5180Why did this record match?
Applicant Name (Manufacturer) :
BUHLMANN Laboratories AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BÜHLMANN fCAL turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of inflammation, in human stool. The BÜHLMANN fCAL turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
The BÜHLMANN CALEX Cap is a single use tube intended for the preparation of human stool samples to be used with the BÜHLMANN fCAL turbo.
Device Description
The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay (PETIA), is performed using patient stool extracts collected without preservatives. Calprotectin within the sample extract mediates immunoparticle agglutination; sample turbidity is proportional to calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation of an established calibration curve. The assay is validated for use on clinical chemistry analyzers such as the Roche cobas® c501/c502 platforms.
The BÜHLMANN fCAL® turbo Reagent Kit is to be used in conjunction with the BÜHLMANN fCAL® turbo Calibrator Kit and BÜHLMANN fCAL® turbo Control Kit, which are available separately.
Sample extracts may be prepared using manual weighing extraction methods or the CALEX® Cap.
The CALEX® Cap is a single use tilled with extraction buffer. The sampling pin houses a dosing tip which is used to obtain sufficient stool sample for the extraction process. The extraction method leads to stool specimen extracts which can be measured directly using the BÜHLMANN fCAL® turbo assay.
Ask a Question
K Number
K190784Device Name
BUHLMANN fCAL turbo
Manufacturer
BUHLMANN Laboratories AG
Date Cleared
2019-06-25
(90 days)
Product Code
NXO
Regulation Number
866.5180Why did this record match?
Applicant Name (Manufacturer) :
BUHLMANN Laboratories AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BÜHLMANN fCAL turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
Device Description
The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay (PETIA), is performed using patient stool extracts collected without preservatives. Calprotectin within the sample extract mediates immunoparticle agglutination; sample turbidity is proportional to calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation of an established calibration curve. The assay is validated for use on clinical chemistry analyzers such as the Roche cobas® c501/c502 platforms.
The BÜHLMANN fCAL® turbo Reagent Kit is to be used in conjunction with the BÜHLMANN fCAL® turbo Calibrator Kit and BÜHLMANN fCAL® turbo Control Kit, which are available separately.
Ask a Question
K Number
K181012Device Name
BUHLMANN fCAL ELISA
Manufacturer
BUHLMANN Laboratories AG
Date Cleared
2018-06-04
(48 days)
Product Code
NXO
Regulation Number
866.5180Why did this record match?
Applicant Name (Manufacturer) :
BUHLMANN Laboratories AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BÜHLMANN fCAL® ELISA is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool. The BÜHLMANN fCAL® ELISA aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
Device Description
The BÜHLMANN fCAL® ELISA is an enzyme-linked immunosorbent assay (ELISA) performed using patient stool extracts collected without preservatives. Calprotectin within the extract binds to protein specific antibodies coated on the well surface. An enzyme conjugated antibody detects the captured antigen. Incubation of the complex with substrate results in a colored product which reflects the amount of calprotectin in the sample. Quantification of calprotectin concentration is achieved using standard plate readers.
Ask a Question
Page 1 of 1