System, Test, Human Chorionic Gonadotropin
FDA product code DHA · Class II (moderate risk) · 21 CFR 862.1155 · Clinical Chemistry
72510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Abbott Laboratories 5
- Germaine Laboratories, Inc. 4
- Roche Diagnostics Corp. 3
- Diagnostic Products Corp. 3
- Dade Behring, Inc. 3
- Princeton BioMeditech Corp. 2
- Diazyme Laboratories 2
- Johnson & Johnson Clinical Diagnostics, Inc. 2
- Ortho-Clinical Diagnostics 2
- Beckman Coulter Inc. 2
- Siemens Healthcare Diagnostics, Inc. 2
- Boehringer Mannheim Corp. 2
- Leeco Diagnostics, Inc. 2
- Baxter Healthcare Corp 2
- Azog, Inc. 2
- Diamedix Corp. 1
- Princeton Biomedix 1
- Shenzhen Yhlo Biotech Co., Ltd. 1
- Pacific Biotech, Inc. 1
- Synbiotics Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | Ortho Clinical Diagnostics | 05/08/2024SE |
| 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 |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA · Traditional | Abbott Laboratories | 10/23/2017SE |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test SystemDHA · Traditional | Diazyme Laboratories | 08/18/2017SE |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG…DHA · Traditional | Abbott Point of Care, Inc. | 04/16/2015SE |
| K130020 | Access Total BHCG (5TH Is)DHA · Traditional | Beckman Coulter, Inc. | 10/01/2013SE |
| K131037 | Liaison XL HCGDHA · Traditional | DiaSorin, Inc. | 09/06/2013SE |
| K072500 | One Step HCG Urine/Serum TestDHA · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 04/21/2009SE |
| K080094 | Olympus Total BHCG Test SystenDHA · Traditional | Olympus Life Science Research Europa GmbH (Europa) | 09/03/2008SE |
| K063720 | Vitros Immunodiagnostic Products Total B-Hcg II Reagent Pack, Calibrators, Range VerifiersDHA · Traditional | Ortho-Clinical Diagnostics | 04/09/2007SE |
| K063754 | Dimension Vista (TM) BHCG Flex(R) Reagent Cartridge, and BHCG Calibrator, Model#…DHA · Traditional | Dade Behring, Inc. | 02/23/2007SE |
| K060548 | Stratus CS Acute Care Betahcg and Nt-Probnp Testpak and Testpak Assay, Calpak and DilpakDHA · Traditional | Dade Behring, Inc. | 04/06/2006SE |
| K042676 | Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) AssayDHA · Traditional | Nichols Institute Diagnostics | 12/17/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | Diagnostic Products Corp. | 12/12/2003SE |
| K031052 | Carestart HCG One-Step Pregnancy TestDHA · Traditional | Access Bio Incorporate | 06/13/2003SE |
| K022681 | Azog, Inc. HCG One-Step Urine Pregnancy Test (Device or Cassette)DHA · Traditional | Azog, Inc. | 11/01/2002SE |
| K022680 | Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)DHA · Traditional | Azog, Inc. | 11/01/2002SE |
| K013857 | Aimstep PregnancyDHA · Traditional | Germaine Laboratories, Inc. | 01/22/2002SE |
| K013678 | Victorch Meditek's HCG Test CardDHA · Traditional | Victorch Meditek, Inc. | 12/27/2001SE |
| K003696 | Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG…DHA · Traditional | Dade Behring, Inc. | 01/25/2001SE |
| K003178 | Elecsys HCG and Beta Test SystemDHA · Traditional | Roche Diagnostics Corp. | 12/14/2000SE |
| K002148 | Elecsys HCG Test SystemDHA · Traditional | Roche Diagnostics Corp. | 08/22/2000SE |
| K000844 | Absolute HCG Pregnancy TestDHA · Traditional | Mizuho USA, Inc. | 06/16/2000SE |
| K994085 | Immulite Turbo HCG, Models LSKCG1, LSKCG5DHA · Traditional | Diagnostic Products Corp. | 01/28/2000SE |
| K991532 | DRX Qt. HCGDHA · Traditional | Metrika, Inc. | 09/17/1999SE |
| K991515 | Insure Pregnancy TestDHA · Traditional | Inbios Intl., Inc. | 05/28/1999SE |
| K990222 | Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6DHA · Traditional | Diagnostic Products Corp. | 02/26/1999SE |
| K983424 | Abbott Archeitect Total B-HcgDHA · Traditional | Abbott Laboratories | 12/01/1998SE |
| K974512 | Aimstick PBD Combo PregnancyDHA · Traditional | Germaine Laboratories, Inc. | 01/02/1998SE |
| K974368 | Aimstick PBD PregnancyDHA · Traditional | Germaine Laboratories, Inc. | 01/02/1998SE |
| K974425 | Biosign Hcg-One Step Pregnancy Test, Accusign Hcg-One Step Pregnancy Test, Lifesign…DHA · Traditional | Princeton BioMeditech Corp. | 12/24/1997SE |
| K973825 | Midstream Home Regnancy TestDHA · Traditional | Germaine Laboratories, Inc. | 12/19/1997SE |
| K970894 | Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (GEM.1075), Total B-Hcg…DHA · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 04/14/1997SE |
| K970387 | Human Chorionic Gonadotropin MethodDHA · Traditional | Dade Chemistry Systems, Inc. | 03/10/1997SE |
| K961792 | Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay ControlsDHA · Traditional | Biocircuits Corp. | 08/21/1996SE |
| K961487 | Elecsys HCG AssayDHA · Traditional | Boehringer Mannheim Corp. | 06/12/1996SE |
| K961351 | HCG Er Method for the Technicon Immuno 1 System In-Vitro Diagnostic Clinical MethodDHA · Traditional | Bayer Corp. | 06/03/1996SE |
| K955707 | Onestep Urine/Serum HCG Module Pregnancy Test KitDHA · Traditional | Excel Scientific, Inc. | 05/02/1996SE |
| K952283 | Amerlite HCG-60 AssayDHA · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 07/17/1995SE |
| K945331 | Auraflex HCGDHA · Traditional | Organon Teknika Corp. | 03/20/1995SE |
| K950307 | Biostrip(R) Hcg-One Step Pregnancy TestDHA · Traditional | Princeton BioMeditech Corp. | 03/01/1995SE |
| K941983 | Sealite Sciences Inc.DHA · Traditional | Sealite Sciences, Inc. | 08/18/1994SE |
| K941090 | Unistep HCG Pregnancy Test StripDHA · Traditional | Biotech Atlantic, Inc. | 06/02/1994SE |
| K932409 | Sas(Tm) Serum/Urine HCGDHA · Traditional | Sa Scientific, Inc. | 06/29/1993SE |
| K922073 | Stratus BHCG Fluorometric Enzyme ImmunoassayDHA · Traditional | Baxter Diagnostics, Inc. | 10/19/1992SE |
| K913236 | Stratus(R) HCG Fluorometric Enzyme ImmunoassayDHA · Traditional | Baxter Healthcare Corp | 08/16/1991SE |
| K911796 | Immulite(Tm) HCGDHA · Traditional | Cirrus Diagnostics, Inc. | 06/20/1991SE |
| K893873 | Single and Dual Band Dipstick HCG TestDHA · Traditional | Ampcor, Inc. | 08/21/1989SE |
| K893953 | Absolute(Tm)-Hcg Urine Pregnancy TestDHA · Traditional | Totem Diagnostics, Inc. | 08/15/1989SE |
| K893577 | Status HCG Fluorometric EnzymeDHA · Traditional | Baxter Healthcare Corp | 08/03/1989SE |
| K892654 | Biostix (Tm)Hcg--Simple Pregnancy TestDHA · Traditional | Princeton Biomedix | 06/19/1989SE |
| K891096 | Vis-Disk HCG (Eia) JPL-041MDHA · Traditional | Leeco Diagnostics, Inc. | 06/16/1989SE |
| K891095 | Vis-Disk HCG (Eia) Lyophilized JPL-044MDHA · Traditional | Leeco Diagnostics, Inc. | 06/16/1989SE |
| K884430 | Serum HCG MicroassayDHA · Traditional | Diamedix Corp. | 12/09/1988SE |
| K883148 | Immuknow-Check HCG Assay Kit, Cat. #900-40DHA · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 12/05/1988SE |
| K884207 | Resubmitted Abbott Testpack(Tm) HCG ComboDHA · Traditional | Abbott Laboratories | 12/02/1988SE |
| K882192 | Hygeia Urine Pregnancy TestDHA · Traditional | Hygeia Sciences | 11/10/1988SE |
| K882896 | One-Step HCGDHA · Traditional | Wampole Laboratories | 10/31/1988SE |
| K882895 | Modified Beta Quik Stat Eia KitDHA · Traditional | Pacific Biotech, Inc. | 10/12/1988SE |
| K883235 | Rapidtest-Hcg (TM)DHA · Traditional | Synbiotics Corp. | 09/30/1988SE |
| K880678 | Modified Ventrescreen Beta HCG Enzyme ImmunoassayDHA · Traditional | Ventrex Laboratories, Inc. | 04/05/1988SE |
| K873986 | Beta-Hcg AssayDHA · Traditional | Schiff & Co. | 02/02/1988SE |
| K873872 | HCG Enzyme Immunoassay Test Kit Catalog #MB-1013DHA · Traditional | Medix Biotech, Inc. | 10/28/1987SE |
| K862108 | Enzymun-Test HCGDHA · Traditional | Boehringer Mannheim Corp. | 08/19/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0958-2023 Class III | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT…Reaction vessels may contain a potential contaminant that could affect their optical performance. | Abbott Laboratories | 11/24/2022Open, Classified |
| Z-1015-2022 Class II | IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG]…Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as… | Siemens Healthcare Diagnostics, Inc. | 02/22/2022Open, Classified |
| Z-0666-2019 Class II | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | Abbott Ireland Diagnostics Division | 11/21/2018Terminated |
| Z-2084-2018 Class II | ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1700-2016 Class II | 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device…When testing was conducted using certain lots, VITROS Systems generated results within the measuring range… | Ortho-Clinical Diagnostics | 02/18/2016Terminated |
| Z-0617-2016 Class II | Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-0615-2016 Class II | Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-1634-2011 | Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |
| Z-1633-2011 | Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |