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510(k) Data Aggregation
K Number
K081150Device Name
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
Manufacturer
Date Cleared
2009-06-16
(419 days)
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
TURKLAB MEDICAL DEVICES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rapidan Optima Early One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use to detect elevated (over the cut-off value of 20 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy.
Toyo One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use and for professional / laboratory use to detect elevated (over the cut-off value of 25 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy. Toyo Pregnancy Test has two formats, a cassette and a test strip format.
Device Description
The device is a qualitative assay based on immuno chromatography principle used to detect elevated levels of hCG over the cut-off value of the device, thus showing signs of pregnancy. Principle of the test; introduced from one end of the membrane, urine mobilizes the anti-hCG antibody complex and moves toward the other end of the membrane passing through the immobilized anti-hCG antibody test region and through the antibody recognizing control region. In the presence of hCG, the test line appears on the membrane together with the control line which confirms the antibody complex arrival to the other end of the membrane. The assay procedure is very simple and fast (introduce sample and wait 5 minutes). The device is designed as draw sample into the pipette, and dispense it onto the sample well of the cassette or dip into sample for strip type. Sampling end is color coded. The interpretation of the result is very easy (2 lines: pregnant, 1 line: not pregnant) even for the lay person.
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