Clongene HCG Pregnancy Rapid Test Cassette, Strip, Midstream
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- HCG Pregnancy Rapid Tests EUDAMED
- Device Name
- HCG Pregnancy Rapid Tests EUDAMED
- Model / Reference
- Strip,Cassette,Midstream EUDAMEDWSHCG1001,WSHCG1002,WSHCG1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-WSHCG100WM EUDAMED
- Basic UDI-DI
- B-WSHCG100WM EUDAMED
- 510(k) Number
- K193132 FDA 510(k)
- FDA Product Code
- LCX FDA 510(k)
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
Yes
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
This device is a rapid diagnostic test classified as a Kit, Test, Pregnancy, HCG, Over-The-Counter under FDA nomenclature. It employs an immuno-chromatographic assay to qualitatively detect human chorionic gonadotropin (hCG) in urine, enabling early pregnancy confirmation. The test functions via a lateral flow sandwich assay, providing visual results within minutes.
The Clongene HCG Pregnancy Rapid Test is supplied as single-use, non-sterile cassettes, strips, or midstream devices intended for in vitro diagnostic self-testing. It is classified as Device Class 2 and regulated under FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD). Available in multiple formats, it requires no specialized equipment and is designed for use by lay users in home settings.
Frequently asked questions
What types of formats are available for the Clongene HCG Pregnancy Rapid Test, and how do they differ in use?
The Clongene HCG Pregnancy Rapid Test is available in three formats: cassette, strip, and midstream. The cassette and strip formats require a small urine sample applied directly to the test device, while the midstream format is designed for use with continuous urine flow—ideal for users who prefer not to collect a sample in a container. All formats use the same immuno-chromatographic assay to detect hCG in urine, providing results within minutes.
Is the Clongene HCG Pregnancy Rapid Test intended for professional lab use, or is it meant for home testing by individuals?
The Clongene HCG Pregnancy Rapid Test is explicitly designed for in vitro diagnostic self-testing in home settings. It is classified as an Over-The-Counter (OTC) pregnancy test kit, meaning it is intended for use by lay users without requiring specialized equipment or professional interpretation. No lab setup is necessary.
Are the Clongene HCG Pregnancy Rapid Test devices single-use, and what does that mean for storage and handling?
Yes, the Clongene HCG Pregnancy Rapid Test is single-use only, meaning each cassette, strip, or midstream device is intended for one test and should not be reused. This design ensures accuracy and hygiene. Storage should follow manufacturer guidelines to maintain test integrity, typically in a cool, dry place away from direct sunlight until use.
What regulatory pathways have been followed for the Clongene HCG Pregnancy Rapid Test, and what does that imply for its use?
The Clongene HCG Pregnancy Rapid Test has undergone FDA 510(k) clearance and complies with the In Vitro Diagnostic Device Directive (IVDD). This means the device has been evaluated for safety, performance, and equivalence to predicate products, ensuring it meets regulatory standards for diagnostic accuracy and reliability. The clearance confirms its suitability for the intended use as a qualitative pregnancy test.
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: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy ..., HCG Pregnancy Rapid Test (Self-testing） - clongene.com, CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193132 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
Sources (3)
- FDA 510(k) K193132 24 fields · synced Oct 6, 2026
- EUDAMED a3376b0d-19e3-4190-8b46-7bae63a5e48b-1 61 fields · synced Jul 12, 2026
- EUDAMED a3376b0d-19e3-4190-8b46-7bae63a5e48b-2 61 fields · synced Jul 12, 2026