HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240242

by Anhui Deepblue Medical Technology Co., Ltd

Identifiers

510(k) Number: K240242 FDA 510(k)
FDA Product Code: LCX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1155 FDA 510(k)
Regulation Number: 862.1155 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a rapid chromatographic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It aids in the early detection of pregnancy and is intended for over-the-counter use, available in strip, cassette, and midstream formats using colloidal gold technology.

The tests are supplied as single-use diagnostic devices, requiring no sterilisation or reprocessing. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance and IVDD authorisation. Each variant (strip, cassette, midstream) is packaged individually for home use, with no MRI safety considerations. Storage follows standard over-the-counter medical device guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use ..., K240242 - HCG Home Use Pregnancy Test Strip (Colloidal G..., HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K240242	Class II	Active

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Manufacturer

Manufacturer: Anhui Deepblue Medical Technology Co., Ltd
FDA Applicant: Anhui Deepblue Medical Technology Co., Ltd.

Sources (2)

FDA 510(k) K240242 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026