i-STAT
The i-STAT Total Beta-hCG cartridge measures beta-human chorionic gonadotropin in venous whole blood or plasma. It provides quantitative and qualitative results as an aid in the early…
The i-STAT Total Beta-hCG cartridge measures beta-human chorionic gonadotropin in venous whole blood or plasma. It provides quantitative and qualitative results as an aid in the early detection of pregnancy. The test uses a two-site enzyme-linked immunoassay with electrochemical detection.
Monoclonal antibodies on the sensor chip capture the beta subunit of hCG. A second antibody, linked to alkaline phosphatase, binds another site on the molecule. The enzyme reacts with a substrate to produce a signal that the electrochemical sensor detects.
Listed Item
CARTRIDGE, Total B-hCG
Measurement
The test has an analysis time of 10 minutes and a reportable range of 5.0 to 2000.0 IU/L. A reference sensor on the same chip is constructed similarly to the hCG sensor but lacks the hCG-specific capture antibodies.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Abbott Point OF Care Inc., United States |
|---|---|
| FDA product code | DHA |
| Device type | System, Test, Human Chorionic Gonadotropin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K133002 |
| Record published | 2016-09-09 |
| Record revised | 2023-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
| Packaging | Case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05p58-25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSign® hCG card | Princeton BioMeditech Corp. | 5 |
| Architect | Abbott Ireland | 5 |
| BioStrip® P | Princeton BioMeditech Corp. | 4 |
| AccuHome Pregnancy Test | Germaine Laboratories, Inc. | 3 |
| Elecsys HCG Test System | Roche Diagnostics Gmbh | 3 |
| Status hCG card | Princeton BioMeditech Corp. | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Maglumi 2000 HCG/beta-HCG | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Access Total BhCG (5th IS) | Beckman Coulter, Inc. | 2 |
| Immulite®/Immulite® 1000 Systems HCG Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Alinity | Abbott Ireland | 2 |
| Immulite® 2000 Systems HCG | Siemens Healthcare Diagnostics Products GmbH | 2 |
Showing 12 of 46. All products under System, Test, Human Chorionic Gonadotropin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133002 | 2015-04-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.