i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
FDA 510(k) K133002 · Abbott Point of Care, Inc.
510(k) numberK133002
Submission
- Device name
- i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
- Applicant
- Abbott Point of Care, Inc.
Princton, NJ, US - Received
- September 24, 2013
- Decision date
- April 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)DHA · Traditional | Shenzhen Yhlo Biotech Co., Ltd. | 12/11/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | Abbott Laboratories | 06/05/2023SE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | Abbott Laboratories | 05/19/2023SE |
| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | Diazyme Laboratories, Inc. | 12/13/2021SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
| K200210 | ADVIA Centaur® Total hCG assayDHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2021SE |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | Shenzhen New Industries Biomedical Engineering… | 01/17/2020SE |
| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
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| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | 05/02/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | 01/03/2025SE |
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| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | 10/27/2023SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | 10/27/2023SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | 10/27/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | 09/15/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | 09/11/2023SE |
Questions and answers
When was i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials cleared by the FDA?
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002) received a 510(k) decision of Substantially Equivalent on April 16, 2015, 569 days after the submission was received.
What is the product code of K133002?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.