Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test
510(k) K964155
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964155 | Date25 Nov 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a visual, prescription-use pregnancy hCG test designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum. It functions as a rapid immunoassay, employing a lateral flow, solid-phase sandwich-format immunochromatographic assay to identify hCG levels for early pregnancy confirmation. The test is intended for use in clinical chemistry settings, including physicians' offices and laboratories, to provide qualitative results based on visual interpretation of test strips.
The device is supplied as a single-use, non-sterile diagnostic test kit, with no specific MRI safety considerations noted. It is available in multiple reference codes and is regulated under FDA 510(k) clearance (K964155) as substantially equivalent to predicate devices. Storage and handling instructions are not detailed in the provided data, but compliance with standard diagnostic test protocols is implied. The device is classified under FDA product code JHI and falls under Class II medical devices, adhering to regulatory requirements for clinical chemistry applications.
Other devices from Genzyme Diagnostics
Questions
AI-generated answers, 1 Oct 2026
What is the Contrast HCG Urine/Serum Test Kit used for?
This device is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum samples. It uses a rapid immunoassay with a lateral flow, solid-phase sandwich-format immunochromatographic assay to confirm early pregnancy in clinical chemistry settings, such as physicians' offices or laboratories. The test provides visual results based on the appearance of test strips.
How is the Contrast HCG Urine/Serum Test Kit supplied?
The test kit is supplied as a single-use diagnostic tool, meaning each kit is intended for one-time use only. It is non-sterile, so proper handling and adherence to standard diagnostic test protocols are recommended to ensure accurate results. The kit is available in multiple reference codes, allowing for flexibility in clinical settings.
Is the Contrast HCG Urine/Serum Test Kit sterile?
No, the Contrast HCG Urine/Serum Test Kit is explicitly noted as non-sterile. Since it is intended for clinical use, it must be handled in accordance with standard diagnostic test protocols to maintain accuracy and reliability. Sterility is not required for this type of qualitative diagnostic test.
What regulatory clearance does the Contrast HCG Urine/Serum Test Kit have?
The device holds FDA 510(k) clearance under the reference number K964155. This clearance indicates that it is classified as substantially equivalent to predicate devices and adheres to regulatory requirements for Class II medical devices under FDA product code JHI. The test is intended for use in clinical chemistry applications.
Are there different models or sizes available for the Contrast HCG Urine/Serum Test Kit?
Yes, the kit is available in multiple reference codes, which likely correspond to different model or lot variations. These variations may cater to different clinical needs or batch specifications, but all follow the same core design and functionality for detecting hCG in urine or serum. The exact specifications for each reference code would be detailed in the accompanying documentation.