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510(k) Data Aggregation
K Number
K251053Device Name
Shinetell PlusTM Digital Early Pregnancy Test
Manufacturer
Hangzhou AllTest Biotech Co., Ltd.
Date Cleared
2025-07-15
(102 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou AllTest Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241978Device Name
Shinetell Digital Pregnancy Test
Manufacturer
Hangzhou AllTest Biotech Co., Ltd.
Date Cleared
2024-08-13
(39 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou AllTest Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
Device Description
Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format. Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
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K Number
K231698Device Name
AllTest Fentanyl Rapid Test (Urine)
Manufacturer
Hangzhou AllTest Biotech Co., Ltd.
Date Cleared
2023-07-31
(49 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou AllTest Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Device Description
AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
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