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510(k) Data Aggregation
K Number
K072901Device Name
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
Manufacturer
Date Cleared
2008-07-01
(264 days)
Product Code
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
AMDL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AMDL-ELISA DR-70® (FDP) immunoassay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of DR-70® (FDP) in human serum. Serial testing using the AMDL- ELISA DR-70® (FDP) is to be used as an aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer. Results of DR-70® (FDP) testing should be used in conjunction with other clinical modalities that are standard of care for monitoring disease progression in these patients.
Device Description
The AMDL, Inc. DR-70® (FDP) assay is an ELISA based assay utilizing removable strips in a 96 micro titer plate well format. The wells are coated with affinity purified rabbit anti-DR-70® (FDP) antibodies. The DR-70® (FDP) in diluted sera (1:200) is captured from the sera by these antibodies immobilized on the well of a micro titer plate. After a wash step, anti-DR-70® (FDP) antibodies conjugated to horseradish peroxidase are added to the wells. If the DR-70® (FDP) antigen is present, the anti-human fibrinogen peroxidase complex will bind to the captured tumor marker to form an immunological sandwich with the immobilized antibodies. After a second wash step, the enzyme substrate 3,3',5'-tetramethylbenzidine (TMB) is added to the well. The end point is read in a micro plate reader at 450 nm once the reaction is stopped with 0.1N HCl. The intensity of the color formed is proportional to the amount of DR-70® (FDP) in the serum. The amount is quantified by interpolation from a standard curve using the calibrators provided with the kit.
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K Number
K981396Device Name
PYLORIPROBE
Manufacturer
Date Cleared
1998-07-30
(104 days)
Product Code
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
AMDL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test is not to be used with asymptomatic patients. The tests are carried out in clinical laboratories by laboratory technologists / technicians and the test results are measured in a microtiter plate reader instrument.
Device Description
PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori.
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