Home Pregnancy Test Kit HPK #1
FDA 510(k)Class II (US FDA 510(k))
by Quidel Corp.
Identifiers
- 510(k) Number
- K831051 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)
The Home Pregnancy Test Kit HPK #1 is a device intended for the early detection of pregnancy by measuring human chorionic gonadotropin (HCG), a placental hormone, in urine. This test system is designed for over-the-counter use and provides results at home.
The kit is supplied as a Class II device under product code LCX with special controls. It is authorized by the FDA with 510(k) clearance number K831051, granted on May 18, 1983. The device is manufactured by Quidel Corp. and is regulated under 862.1155.
Frequently asked questions
What is the Home Pregnancy Test Kit HPK #1 used for?
The Home Pregnancy Test Kit HPK #1 is designed for the early detection of pregnancy by measuring human chorionic gonadotropin (HCG), a placental hormone, in urine. It is intended for over-the-counter use and provides results at home.
How is the Home Pregnancy Test Kit HPK #1 supplied?
The kit is supplied as a Class II device under product code LCX with special controls. It is manufactured by Quidel Corp. and is designed for single-use at home to detect pregnancy through urine sample testing.
What is the regulatory status of the Home Pregnancy Test Kit HPK #1?
The device is authorized by the FDA with 510(k) clearance number K831051, granted on May 18, 1983. It is regulated under 862.1155 and is classified as substantially equivalent to predicate devices.
Is the Home Pregnancy Test Kit HPK #1 reusable?
The Home Pregnancy Test Kit HPK #1 is designed for single-use only. Each test kit contains all necessary components for one pregnancy test and should not be reused to ensure accurate results.
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: K831051 FDA 510 (k) - HOME PREGNANCY TEST KIT HPK #1, HOME PREGNANCY TEST KIT HPK #1 (K831051) — FDA 510 (k) | Innolitics, HOME PREGNANCY TEST KIT HPK #1 510 (k) K831051 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831051 | Class II | Active |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA 510(k) K831051 24 fields · synced Sep 27, 2026