DHA · System, Test, Human Chorionic Gonadotropin
Clinical Chemistry · 21 CFR 862.1155 · Class 2
Overview
| Product Code | DHA |
|---|---|
| Device Name | System, Test, Human Chorionic Gonadotropin |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
Classification Rationale
For early detection of pregnancy: Class II. For any uses other than early detection of pregnancy: Class III.
Recent Cleared Devices (20 of 72)
Showing 20 most recent of 72 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | May 8, 2024 | SESE |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | Dec 11, 2023 | SESE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | Jun 5, 2023 | SESE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Laboratories | May 19, 2023 | SESE |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | Dec 27, 2022 | SESE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | Diazyme Laboratories, Inc. | Dec 13, 2021 | SESE |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | Aug 18, 2021 | SESE |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | Jul 13, 2021 | SESE |
| K192547 | MAGLUMI 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Jan 17, 2020 | SESE |
| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | Oct 30, 2019 | SESE |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | Oct 23, 2017 | SESE |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories | Aug 18, 2017 | SESE |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials | Abbott Point of Care, Inc. | Apr 16, 2015 | SESE |
| K130020 | ACCESS TOTAL BHCG (5TH IS) | Beckman Coulter, Inc. | Oct 1, 2013 | SESE |
| K131037 | LIAISON XL HCG | DiaSorin, Inc. | Sep 6, 2013 | SESE |
| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | Apr 21, 2009 | SESE |
| K080094 | OLYMPUS TOTAL BHCG TEST SYSTEN | Olympus Life Science Research Europa GmbH (Europa) | Sep 3, 2008 | SESE |
| K063720 | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS | Ortho-Clinical Diagnostics | Apr 9, 2007 | SESE |
| K063754 | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 | Dade Behring, Inc. | Feb 23, 2007 | SESE |
| K060548 | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK | Dade Behring, Inc. | Apr 6, 2006 | SESE |
Top Applicants
- Abbott Laboratories — 5 clearances
- Germaine Laboratories, Inc. — 4 clearances
- Dade Behring, Inc. — 3 clearances
- Diagnostic Products Corp. — 3 clearances
- Azog, Inc. — 2 clearances
