Abbott Laboratories B-HCG EIA
by Abbott Laboratories 510(k)
Active
510(k) K820271
Overview
The Abbott Laboratories B-HCG EIA is an Enzyme Immunoassay (EIA) device designed for the qualitative detection of human chorionic gonadotropin (HCG) in urine or plasma. HCG is a hormone produced during pregnancy, and this test is intended for uses beyond early pregnancy detection, such as aiding in the diagnosis, prognosis, and management of certain tumors or carcinomas.
This device is supplied as a prescription-use diagnostic tool, classified under product code JHI and regulated under FDA 510(k) clearance (K820271). It is intended for single-use in clinical chemistry settings and requires no special sterility beyond standard laboratory protocols. The device is non-reusable and must be stored according to manufacturer instructions to maintain integrity. No MRI safety information is specified, and regulatory status is limited to the stated FDA clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820271 | Date11 Mar 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Abbott Laboratories
Questions
What clinical scenarios is the Abbott Laboratories B-HCG EIA primarily used for beyond early pregnancy detection?
The Abbott Laboratories B-HCG EIA is designed for the qualitative detection of human chorionic gonadotropin (HCG) in urine or plasma, which aids in diagnosing, monitoring, and managing conditions beyond pregnancy, such as certain tumors or carcinomas. HCG levels can be indicative of gestational trophoblastic disease or other malignancies producing HCG, making this test valuable in oncology settings.
Is this device intended for single-use or can it be reused in a clinical setting?
The Abbott Laboratories B-HCG EIA is explicitly intended for single-use only. It is not designed or cleared for reuse, so each test kit should be discarded after a single use to ensure accuracy and prevent contamination.
What storage conditions must be followed to maintain the integrity of the Abbott Laboratories B-HCG EIA?
The device must be stored according to the manufacturer’s instructions to preserve its integrity. While the data does not specify exact storage conditions (like temperature or humidity), standard laboratory protocols for diagnostic reagents should be followed to ensure reliability and prevent degradation.
How is the Abbott Laboratories B-HCG EIA regulated, and what does the product code JHI indicate?
The Abbott Laboratories B-HCG EIA is regulated under the FDA’s 510(k) clearance pathway (K820271) and is classified under product code JHI, which corresponds to 'Visual, Pregnancy HCG, Prescription Use' devices. This classification confirms it is a prescription-only diagnostic tool intended for clinical chemistry use, specifically for qualitative HCG detection in urine or plasma.
Are there any special handling requirements for this device, such as sterility or compatibility with other systems?
The device does not require special sterility beyond standard laboratory protocols, as it is intended for use in clinical chemistry settings where contamination control is already in place. There is no mention of MRI safety or compatibility with other systems, so it should be used strictly as an in-vitro diagnostic tool without additional environmental or equipment constraints.