Clearblue Early Pregnancy Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213379 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 Pregnancy Test Kit, designed to detect human chorionic gonadotropin (hCG) in urine, indicating early pregnancy. It provides a qualitative result to confirm the presence of hCG, a hormone produced during pregnancy, enabling early detection before a missed period.
The test is intended for over-the-counter use and is supplied as a single-use, non-sterile diagnostic device. It is classified as Class II under FDA regulations and requires no special storage conditions beyond room temperature. The device has received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent) in the Clinical Chemistry advisory committee.
Frequently asked questions
What is the Clearblue Early Pregnancy Test used for and how does it work?
The Clearblue Early Pregnancy Test detects the presence of human chorionic gonadotropin (hCG) in urine, a hormone produced during early pregnancy. It provides a qualitative result to confirm pregnancy before a missed period, allowing users to determine if they are pregnant as early as five days before their expected cycle. The test is designed for over-the-counter use and is intended for home testing.
Is the Clearblue Early Pregnancy Test single-use or reusable?
The Clearblue Early Pregnancy Test is explicitly designed as a single-use device. Each test is intended for one-time use only, ensuring accuracy and hygiene for each individual test.
What storage conditions are required for the Clearblue Early Pregnancy Test?
No special storage conditions are required for the Clearblue Early Pregnancy Test. It can be stored at room temperature, making it convenient for home use without the need for refrigeration or controlled environments.
How was the regulatory approval process for the Clearblue Early Pregnancy Test handled?
The Clearblue Early Pregnancy Test received FDA 510(k) clearance through the Traditional pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. The decision was made by the Clinical Chemistry advisory committee, and the device is classified as Class II under FDA regulations.
Is the Clearblue Early Pregnancy Test sterile?
The Clearblue Early Pregnancy Test is explicitly labeled as a non-sterile diagnostic device. Since it is intended for single-use and home testing, sterility is not required for its intended use.
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: SPD — Our products, SPD - Swiss Precision Diagnostics GmbH, Pregnancy Tests, Ovulation Tests and Fertility Monitor - Clearblue
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213379 | Class II | Active |
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Manufacturer
- Manufacturer
- Spd Swiss Precision Diagnostics Gmbh
Sources (1)
- FDA 510(k) K213379 24 fields · synced Sep 19, 2026