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510(k) Data Aggregation
K Number
K171136Device Name
LIA Pregnancy Test
Manufacturer
Date Cleared
2017-11-20
(217 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
LIA Diagnostics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Device Description
The Lia Pregnancy Test is an in vitro diagnostic device for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. The method employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify hCG in the test samples. The sensitivity of the test has been adjusted to 22mlU/mL. The Lia Pregnancy Test is a lateral flow chromatographic immunoassay. When a mid-stream urine sample is applied to the absorbent end, the sample enters the device by capillary action and mixes with the antibody-dye coniugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti-alpha hCG polyclonal antibody) membrane. During the test, hCG in the urine specimen reacts with the dye conjugate and forms a complex. The complex migrates along the cellulose strip to the α-hCG antibody line (T), and remains captured in the T line. As a result, a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The control line develops in the Control (C) zone regardless of the result.
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