In-Home Early Pregnancy Test Kit
510(k) K802334
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802334 | Date10 Oct 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JHJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is an Agglutination Method, Human Chorionic Gonadotropin (hCG) test kit for in-home use, designed to detect early pregnancy by identifying hCG in urine samples. Classified under Clinical Chemistry, it provides a qualitative result indicating the presence of hCG, a hormone produced during pregnancy. The test follows a substantially equivalent regulatory pathway under FDA 510(k) clearance (K802334).
The kit is intended for single-use, non-invasive home testing and requires no professional administration. Supplied as a Class II medical device, it is not sterile and must be handled according to manufacturer instructions. Storage conditions are not specified in the regulatory data, but typical home diagnostic tests require protection from moisture and extreme temperatures. Authorized under FDA 510(k) clearance, it adheres to regulatory standards for in-home pregnancy testing.
Other devices from Health Diagnostics Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of results does this pregnancy test provide, and how should I interpret them?
This test provides a qualitative result, meaning it only indicates whether human chorionic gonadotropin (hCG) is present in your urine, which is a hormone associated with pregnancy. A positive result suggests pregnancy, while a negative result indicates no detectable hCG. Follow the manufacturer’s instructions for precise interpretation, as the test uses an agglutination method to detect hCG levels.
Is this test kit sterile, and how should I handle it to ensure accuracy?
This test kit is not sterile, so it should be handled with clean, dry hands or gloves to avoid contamination. Since it’s designed for single-use, avoid reusing any components. Follow the manufacturer’s guidelines for proper storage (e.g., protecting from moisture and extreme temperatures) to maintain test integrity.
Can I reuse any part of this test kit, or is it meant for one-time use only?
The kit is explicitly designed for single-use only, meaning each test component (e.g., test strips, collection cup) should not be reused. Reusing parts could compromise accuracy or introduce contamination, so discard the entire kit after one use as directed by the manufacturer.
What regulatory pathway does this device follow, and how does that affect its use?
This test was cleared under the FDA’s 510(k) pathway (K802334) as substantially equivalent to a predicate device, ensuring it meets regulatory standards for in-home pregnancy testing. The clearance confirms its safety and performance for detecting hCG in urine, but it’s still critical to follow the manufacturer’s instructions for proper use and interpretation.
Are there specific storage conditions I should follow for this test kit?
While exact storage conditions aren’t detailed in the regulatory data, typical in-home diagnostic tests like this one should be kept dry and protected from extreme temperatures or moisture. Check the manufacturer’s packaging for any additional guidance, as improper storage could affect test reliability.