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510(k) Data Aggregation
K Number
K141874Device Name
URISCAN OPTIMA
Manufacturer
YD DIAGNOSTICS CORP.
Date Cleared
2015-05-28
(321 days)
Product Code
KQO, JFY, JIR
Regulation Number
862.2900Why did this record match?
Applicant Name (Manufacturer) :
YD DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The URISCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URISCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results.
The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters;
Albumin Creatinine ACR (Albumin Creatinine Ratio)
These measurements are useful in the evaluation of renal, urinary and metabolic disorders. URiSCAN Optima urine chemistry test system is intended for prescription use only, in clinical laboratory and in point-of-care setting.
Device Description
URiSCAN Optima - the semi-quantitative urine analyzer is used with the aim of helping examine patients in a professional setting through early detection of disease before they get a thorough checkup, by using chemical components contained in urine; and it is a device to measure the amounts of components in urine, including albumin, creatinine and ACR (albumin creatinine ratio). The results appear on a liquid crystal display and can be printed on the analyzer's internal printer and transferred to a host computer, if desired.
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K Number
K060953Device Name
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
Manufacturer
YD DIAGNOSTICS CORP.
Date Cleared
2006-09-18
(165 days)
Product Code
KHE
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
YD DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OcculTech Occult Blood Rapid Test is a card type rapid test and an immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g. diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.
Device Description
The OcculTech Fecal Occult Blood Rapid Test is a colloidal gold enhanced immunoassay for the detection of hemoglobin in human stool. During the assay the specimen stool are absorbed into the sample pad and migrate upwards chromatographically on the membrane by capillary action. The specimen stool extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a simple operation and a number of specimen can be treated in minimal time.
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