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RapidHCG Pregnancy Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981770

by Rapid Diagnostics Inc

Identifiers

510(k) Number
K981770 FDA 510(k)
FDA Product Code
JHI 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 RapidHCG Pregnancy Test is a visual, prescription-use device classified as a pregnancy hCG test. It functions as a rapid chromatographic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum, aiding in the early identification of pregnancy. The test relies on immunochemical principles to provide a rapid result, typically within minutes of sample application.

This device is supplied as a single-use, non-sterile diagnostic tool intended for use in clinical chemistry settings, such as physician offices or hospitals. It requires no special storage conditions beyond protection from extreme temperatures and moisture. The RapidHCG Pregnancy Test holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of June 5, 1998, and is categorized under the product code JHI. It is not intended for MRI use or reusable applications.

Frequently asked questions

What is the RapidHCG Pregnancy Test used for?

The RapidHCG Pregnancy Test is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum samples. It helps clinicians identify early pregnancy by identifying the presence of hCG, a hormone produced during pregnancy, through a rapid chromatographic immunoassay. This test is intended for use in clinical chemistry settings, such as physician offices or hospitals, to provide results within minutes of sample application.

How is the RapidHCG Pregnancy Test supplied and stored?

The RapidHCG Pregnancy Test is supplied as a single-use device, meaning each test is intended for one-time use only. It is non-sterile and does not require specialized storage conditions beyond protection from extreme temperatures and moisture. Store the test in its original packaging until ready for use to maintain its integrity.

Is the RapidHCG Pregnancy Test reusable or single-use?

The RapidHCG Pregnancy Test is explicitly designed for single-use only. After a single test application, the device should be discarded to ensure accuracy and prevent contamination. Reusing the test could compromise its performance and reliability, as it is not intended for repeated use.

What regulatory pathway does the RapidHCG Pregnancy Test follow?

The RapidHCG Pregnancy Test holds an FDA 510(k) clearance under the Traditional pathway, demonstrating that it is substantially equivalent to a legally marketed device. This clearance was granted on June 5, 1998, and the test is categorized under product code JHI. The regulatory route confirms its compliance with FDA standards for use in clinical settings.

Can the RapidHCG Pregnancy Test be used with MRI or other imaging equipment?

No, the RapidHCG Pregnancy Test is not intended for use with MRI or any other imaging equipment. It is a standalone diagnostic device designed for direct application of urine or serum samples to detect hCG levels. Always follow the manufacturer’s instructions for proper use and disposal.

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: Citest Diagnostics Inc, Rapid Diagnostics, Inc. FDA 510 (k) Products (1998-2004), Rapid Diagnostics Tests - hemocue.com, Immunostics Inc | Rapid Diagnostics, Rapid Response® Pregnancy Test Strip - 50 | BTNX Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rapid Diagnostics Inc
FDA Applicant
Rapid Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K981770 24 fields · synced Oct 1, 2026