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.
Cleared Devices (72)
| 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 |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | Nichols Institute Diagnostics | Dec 17, 2004 | SESE |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Diagnostic Products Corp. | Dec 12, 2003 | SESE |
| K031052 | CARESTART HCG ONE-STEP PREGNANCY TEST | Access Bio Incorporate | Jun 13, 2003 | SESE |
| K022681 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) | Azog, Inc. | Nov 1, 2002 | SESE |
| K022680 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) | Azog, Inc. | Nov 1, 2002 | SESE |
| K013857 | AIMSTEP PREGNANCY | Germaine Laboratories, Inc. | Jan 22, 2002 | SESE |
| K013678 | VICTORCH MEDITEK'S HCG TEST CARD | Victorch Meditek, Inc. | Dec 27, 2001 | SESE |
| K003696 | STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD | Dade Behring, Inc. | Jan 25, 2001 | SESE |
| K003178 | ELECSYS HCG AND BETA TEST SYSTEM | Roche Diagnostics Corp. | Dec 14, 2000 | SESE |
| K002148 | ELECSYS HCG TEST SYSTEM | Roche Diagnostics Corp. | Aug 22, 2000 | SESE |
| K000844 | ABSOLUTE HCG PREGNANCY TEST | Mizuho USA, Inc. | Jun 16, 2000 | SESE |
| K994085 | IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 | Diagnostic Products Corp. | Jan 28, 2000 | SESE |
| K991532 | DRX QT. HCG | Metrika, Inc. | Sep 17, 1999 | SESE |
| K991515 | INSURE PREGNANCY TEST | Inbios Intl., Inc. | May 28, 1999 | SESE |
| K990222 | IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 | Diagnostic Products Corp. | Feb 26, 1999 | SESE |
| K983424 | ABBOTT ARCHEITECT TOTAL B-HCG | Abbott Laboratories | Dec 1, 1998 | SESE |
| K974512 | AIMSTICK PBD COMBO PREGNANCY | Germaine Laboratories, Inc. | Jan 2, 1998 | SESE |
| K974368 | AIMSTICK PBD PREGNANCY | Germaine Laboratories, Inc. | Jan 2, 1998 | SESE |
| K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | Dec 24, 1997 | SESE |
| K973825 | MIDSTREAM HOME REGNANCY TEST | Germaine Laboratories, Inc. | Dec 19, 1997 | SESE |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) | Johnson & Johnson Clinical Diagnostics, Inc. | Apr 14, 1997 | SESE |
| K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD | Dade Chemistry Systems, Inc. | Mar 10, 1997 | SESE |
| K961792 | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS | Biocircuits Corp. | Aug 21, 1996 | SESE |
| K961487 | ELECSYS HCG ASSAY | Boehringer Mannheim Corp. | Jun 12, 1996 | SESE |
| K961351 | HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD | Bayer Corp. | Jun 3, 1996 | SESE |
| K955707 | ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT | Excel Scientific, Inc. | May 2, 1996 | SESE |
| K952283 | AMERLITE HCG-60 ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | Jul 17, 1995 | SESE |
| K945331 | AURAFLEX HCG | Organon Teknika Corp. | Mar 20, 1995 | SESE |
| K950307 | BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | Mar 1, 1995 | SESE |
| K941983 | SEALITE SCIENCES INC. | Sealite Sciences, Inc. | Aug 18, 1994 | SESE |
| K941090 | UNISTEP HCG PREGNANCY TEST STRIP | Biotech Atlantic, Inc. | Jun 2, 1994 | SESE |
| K932409 | SAS(TM) SERUM/URINE HCG | Sa Scientific, Inc. | Jun 29, 1993 | SESE |
| K922073 | STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | Oct 19, 1992 | SESE |
| K913236 | STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | Aug 16, 1991 | SESE |
| K911796 | IMMULITE(TM) HCG | Cirrus Diagnostics, Inc. | Jun 20, 1991 | SESE |
| K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST | Ampcor, Inc. | Aug 21, 1989 | SESE |
| K893953 | ABSOLUTE(TM)-HCG URINE PREGNANCY TEST | Totem Diagnostics, Inc. | Aug 15, 1989 | SESE |
| K893577 | STATUS HCG FLUOROMETRIC ENZYME | Baxter Healthcare Corp | Aug 3, 1989 | SESE |
| K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST | Princeton Biomedix | Jun 19, 1989 | SESE |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Leeco Diagnostics, Inc. | Jun 16, 1989 | SESE |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Leeco Diagnostics, Inc. | Jun 16, 1989 | SESE |
| K884430 | SERUM HCG MICROASSAY | Diamedix Corp. | Dec 9, 1988 | SESE |
| K883148 | IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 | Diagnostic Chemicals, Ltd. (Usa) | Dec 5, 1988 | SESE |
| K884207 | RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO | Abbott Laboratories | Dec 2, 1988 | SESE |
| K882192 | HYGEIA URINE PREGNANCY TEST | Hygeia Sciences | Nov 10, 1988 | SESE |
| K882896 | ONE-STEP HCG | Wampole Laboratories | Oct 31, 1988 | SESE |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | Pacific Biotech, Inc. | Oct 12, 1988 | SESE |
| K883235 | RAPIDTEST-HCG (TM) | Synbiotics Corp. | Sep 30, 1988 | SESE |
| K880678 | MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY | Ventrex Laboratories, Inc. | Apr 5, 1988 | SESE |
| K873986 | BETA-HCG ASSAY | Schiff & Co. | Feb 2, 1988 | SESE |
| K873872 | HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 | Medix Biotech, Inc. | Oct 28, 1987 | SESE |
| K862108 | ENZYMUN-TEST HCG | Boehringer Mannheim Corp. | Aug 19, 1986 | SESE |
Top Applicants
- Abbott Laboratories — 5 clearances
- Germaine Laboratories, Inc. — 4 clearances
- Diagnostic Products Corp. — 3 clearances
- Dade Behring, Inc. — 3 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
