Beta-HCG Hemagglutination Test
by Sero-Immuno Diagnostics, Inc. 510(k)
Active
510(k) K842181
Overview
The Beta-HCG Hemagglutination Test is an in vitro diagnostic device classified as an agglutination method for detecting human chorionic gonadotropin (hCG). It employs hemagglutination inhibition principles to identify the presence of beta-subunit hCG in urine, a biomarker associated with pregnancy. This test is designed for qualitative detection, providing a visual readout to confirm or rule out early pregnancy based on antigen-antibody reactions.
This test is supplied as a single-use diagnostic kit and requires no special storage conditions beyond those specified in the accompanying instructions. It is intended for use in clinical chemistry laboratories and is regulated under FDA 510(k) clearance (K842181) as a Class II device under regulation 862.1155. The kit includes all necessary reagents and components for performing the hemagglutination assay, with no additional processing or equipment required beyond standard laboratory practices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842181 | Date22 Aug 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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
Other devices from Sero-Immuno Diagnostics, Inc.
Questions
What clinical setting is this test intended for and how does it work?
The Beta-HCG Hemagglutination Test is designed for use in clinical chemistry laboratories to detect human chorionic gonadotropin (hCG) in urine samples. It uses an agglutination method based on hemagglutination inhibition principles. When hCG is present, it binds to antibodies in the test, preventing red blood cells from clumping together, which provides a visual readout indicating pregnancy. This qualitative test helps confirm or rule out early pregnancy by identifying the beta-subunit of hCG.
Is this test single-use, and if so, what does that mean for my workflow?
Yes, this test is supplied as a single-use diagnostic kit, meaning each kit is intended for one test procedure only. This design ensures accuracy and prevents cross-contamination between samples. You’ll need to use a new kit for each patient’s urine sample, which simplifies workflow by eliminating the need for cleaning or reprocessing between uses.
What storage requirements does this test have, and can it be stored under standard laboratory conditions?
The Beta-HCG Hemagglutination Test does not require special storage conditions beyond those specified in the accompanying instructions. This means it can typically be stored under standard laboratory conditions, such as room temperature or refrigeration if recommended by the manufacturer. Always refer to the included instructions for precise storage guidelines to maintain test validity.
How do I know this test is safe and approved for use in my facility?
This test holds an FDA 510(k) clearance (K842181) as a Class II device under regulation 862.1155, indicating it meets regulatory standards for safety and performance. The clearance was granted through the Clinical Chemistry advisory committee (CH) in 1984, confirming its suitability for detecting hCG in urine samples as part of pregnancy testing. Always verify the latest regulatory status with the manufacturer or FDA records.