FDA Product Code DHA: System, Test, Human Chorionic Gonadotropin
Under FDA product code DHA, human chorionic gonadotropin test systems are cleared for the detection of pregnancy and the monitoring of hCG-producing conditions.
These immunoassays detect hCG — the hormone produced by the placenta after implantation — in urine or serum. They are used for pregnancy confirmation, ectopic pregnancy diagnosis, monitoring of gestational trophoblastic disease, and tumor marker surveillance.
DHA devices are Class II medical devices, regulated under 21 CFR 862.1155 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Abbott Laboratories, Dade Behring, Inc. and Diagnostic Products Corp..
72
Total
72
Cleared
117d
Avg days
1986
Since
Declining activity -
0 submissions in the last 2 years
vs 5 in the prior period
FDA 510(k) Cleared System, Test, Human Chorionic Gonadotropin Devices (Product Code DHA)
72 devices
Cleared
May 08, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
183d
Cleared
Dec 11, 2023
iFlash-HCG
Shenzhen Yhlo Biotech Co., Ltd.
Chemistry
367d
Cleared
Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Abbott Laboratories
Chemistry
63d
Cleared
May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
Abbott Laboratories
Chemistry
58d
Cleared
Dec 27, 2022
Access Total ßhCG (5th IS)
Beckman Coulter, Inc.
Chemistry
174d
Cleared
Dec 13, 2021
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
Diazyme Laboratories, Inc.
Chemistry
150d
Cleared
Aug 18, 2021
Elecsys HCG STAT
Roche Diagnostics
Chemistry
289d
Cleared
Jul 13, 2021
ADVIA Centaur® Total hCG assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
532d
Cleared
Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Chemistry
122d
Cleared
Oct 30, 2019
Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics, Inc.
Chemistry
30d
Cleared
Oct 23, 2017
Alinity i Total ß-hCG Reagent Kit, Alinity i System
Abbott Laboratories
Chemistry
264d
Cleared
Aug 18, 2017
Diazyme DZ-Lite Total beta-hCG Test System
Diazyme Laboratories
Chemistry
255d
Cleared
Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
Beckman Coulter, Inc.
Chemistry
271d
Cleared
Sep 06, 2013
LIAISON XL HCG
DiaSorin, Inc.
Chemistry
144d
Cleared
Apr 21, 2009
ONE STEP HCG URINE/SERUM TEST
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry
594d
Cleared
Apr 09, 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
Ortho-Clinical Diagnostics
Chemistry
115d
Cleared
Feb 23, 2007
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
Dade Behring, Inc.
Chemistry
66d
Cleared
Apr 06, 2006
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
Dade Behring, Inc.
Chemistry
36d
Cleared
Dec 17, 2004
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
Nichols Institute Diagnostics
Chemistry
79d
Cleared
Dec 12, 2003
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
Diagnostic Products Corp.
Chemistry
67d
Cleared
Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
Dade Behring, Inc.
Chemistry
56d
Cleared
Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
64d
Cleared
Aug 22, 2000
ELECSYS HCG TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
36d
Cleared
Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
Diagnostic Products Corp.
Chemistry
56d
About Product Code DHA - Regulatory Context
510(k) Submission Activity
72 total 510(k) submissions under product code DHA since 1986, with 72 receiving FDA clearance (average review time: 117 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 5 in the prior period.