Product Code: DHA FDA class 2 21 CFR 862.1155

System, Test, Human Chorionic Gonadotropin

Clinical Chemistry

The Human Chorionic Gonadotropin (hCG) Test System is a diagnostic assay used to detect and measure human chorionic gonadotropin, a hormone produced during pregnancy and by certain tumors, in blood or urine samples. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification, and is regulated under 21 CFR 862.1155 within the Clinical Chemistry specialty. The device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DHA in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DHA
Device Class: FDA class 2
Regulation Number: 862.1155
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 72 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack	May 08, 2024	Substantially Equivalent	Ortho Clinical Diagnostics
K223690	iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)	Dec 11, 2023	Substantially Equivalent	Shenzhen Yhlo Biotech Co., Ltd.
K230937	Alinity i Total ß-hCG Reagent Kit, GLP systems Track	Jun 05, 2023	Substantially Equivalent	Abbott Laboratories
K230790	Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series	May 19, 2023	Substantially Equivalent	Abbott Laboratories
K221990	Access Total ßhCG (5th IS)	Dec 27, 2022	Substantially Equivalent	Beckman Coulter, Inc.
K212221	Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer	Dec 13, 2021	Substantially Equivalent	Diazyme Laboratories, Inc.
K203227	Elecsys HCG STAT	Aug 18, 2021	Substantially Equivalent	Roche Diagnostics
K200210	ADVIA Centaur® Total hCG assay	Jul 13, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K192547	MAGLUMI 2000 HCG/ß-HCG	Jan 17, 2020	Substantially Equivalent	Shenzhen New Industries Biomedical Engineering Co., Ltd.
K192790	Atellica IM Total hCG (ThCG)	Oct 30, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K170317	Alinity i Total ß-hCG Reagent Kit, Alinity i System	Oct 23, 2017	Substantially Equivalent	Abbott Laboratories
K163418	Diazyme DZ-Lite Total beta-hCG Test System	Aug 18, 2017	Substantially Equivalent	Diazyme Laboratories
K133002	i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials	Apr 16, 2015	Substantially Equivalent	Abbott Point of Care, Inc.
K130020	ACCESS TOTAL BHCG (5TH IS)	Oct 01, 2013	Substantially Equivalent	Beckman Coulter, Inc.
K131037	LIAISON XL HCG	Sep 06, 2013	Substantially Equivalent	DiaSorin, Inc.
K072500	ONE STEP HCG URINE/SERUM TEST	Apr 21, 2009	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K080094	OLYMPUS TOTAL BHCG TEST SYSTEN	Sep 03, 2008	Substantially Equivalent	Olympus Life Science Research Europa GmbH (Europa)
K063720	VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS	Apr 09, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics
K063754	DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632	Feb 23, 2007	Substantially Equivalent	Dade Behring, Inc.
K060548	STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK	Apr 06, 2006	Substantially Equivalent	Dade Behring, Inc.
K042676	NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY	Dec 17, 2004	Substantially Equivalent	Nichols Institute Diagnostics
K033234	IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER	Dec 12, 2003	Substantially Equivalent	Diagnostic Products Corp.
K031052	CARESTART HCG ONE-STEP PREGNANCY TEST	Jun 13, 2003	Substantially Equivalent	Access Bio Incorporate
K022681	AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)	Nov 01, 2002	Substantially Equivalent	Azog, Inc.
K022680	AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)	Nov 01, 2002	Substantially Equivalent	Azog, Inc.
K013857	AIMSTEP PREGNANCY	Jan 22, 2002	Substantially Equivalent	Germaine Laboratories, Inc.
K013678	VICTORCH MEDITEK'S HCG TEST CARD	Dec 27, 2001	Substantially Equivalent	Victorch Meditek, Inc.
K003696	STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD	Jan 25, 2001	Substantially Equivalent	Dade Behring, Inc.
K003178	ELECSYS HCG AND BETA TEST SYSTEM	Dec 14, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K002148	ELECSYS HCG TEST SYSTEM	Aug 22, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000844	ABSOLUTE HCG PREGNANCY TEST	Jun 16, 2000	Substantially Equivalent	Mizuho USA, Inc.
K994085	IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5	Jan 28, 2000	Substantially Equivalent	Diagnostic Products Corp.
K991532	DRX QT. HCG	Sep 17, 1999	Substantially Equivalent	Metrika, Inc.
K991515	INSURE PREGNANCY TEST	May 28, 1999	Substantially Equivalent	Inbios Intl., Inc.
K990222	IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6	Feb 26, 1999	Substantially Equivalent	Diagnostic Products Corp.
K983424	ABBOTT ARCHEITECT TOTAL B-HCG	Dec 01, 1998	Substantially Equivalent	Abbott Laboratories
K974512	AIMSTICK PBD COMBO PREGNANCY	Jan 02, 1998	Substantially Equivalent	Germaine Laboratories, Inc.
K974368	AIMSTICK PBD PREGNANCY	Jan 02, 1998	Substantially Equivalent	Germaine Laboratories, Inc.
K974425	BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST	Dec 24, 1997	Substantially Equivalent	Princeton BioMeditech Corp.
K973825	MIDSTREAM HOME REGNANCY TEST	Dec 19, 1997	Substantially Equivalent	Germaine Laboratories, Inc.
K970894	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)	Apr 14, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K970387	HUMAN CHORIONIC GONADOTROPIN METHOD	Mar 10, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K961792	BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS	Aug 21, 1996	Substantially Equivalent	Biocircuits Corp.
K961487	ELECSYS HCG ASSAY	Jun 12, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K961351	HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD	Jun 03, 1996	Substantially Equivalent	Bayer Corp.
K955707	ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT	May 02, 1996	Substantially Equivalent	Excel Scientific, Inc.
K952283	AMERLITE HCG-60 ASSAY	Jul 17, 1995	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K945331	AURAFLEX HCG	Mar 20, 1995	Substantially Equivalent	Organon Teknika Corp.
K950307	BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST	Mar 01, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K941983	SEALITE SCIENCES INC.	Aug 18, 1994	Substantially Equivalent	Sealite Sciences, Inc.
K941090	UNISTEP HCG PREGNANCY TEST STRIP	Jun 02, 1994	Substantially Equivalent	Biotech Atlantic, Inc.
K932409	SAS(TM) SERUM/URINE HCG	Jun 29, 1993	Substantially Equivalent	Sa Scientific, Inc.
K922073	STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY	Oct 19, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K913236	STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY	Aug 16, 1991	Substantially Equivalent	Baxter Healthcare Corp
K911796	IMMULITE(TM) HCG	Jun 20, 1991	Substantially Equivalent	Cirrus Diagnostics, Inc.
K893873	SINGLE AND DUAL BAND DIPSTICK HCG TEST	Aug 21, 1989	Substantially Equivalent	Ampcor, Inc.
K893953	ABSOLUTE(TM)-HCG URINE PREGNANCY TEST	Aug 15, 1989	Substantially Equivalent	Totem Diagnostics, Inc.
K893577	STATUS HCG FLUOROMETRIC ENZYME	Aug 03, 1989	Substantially Equivalent	Baxter Healthcare Corp
K892654	BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST	Jun 19, 1989	Substantially Equivalent	Princeton Biomedix
K891096	VIS-DISK HCG (EIA) JPL-041M	Jun 16, 1989	Substantially Equivalent	Leeco Diagnostics, Inc.
K891095	VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M	Jun 16, 1989	Substantially Equivalent	Leeco Diagnostics, Inc.
K884430	SERUM HCG MICROASSAY	Dec 09, 1988	Substantially Equivalent	Diamedix Corp.
K883148	IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40	Dec 05, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K884207	RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO	Dec 02, 1988	Substantially Equivalent	Abbott Laboratories
K882192	HYGEIA URINE PREGNANCY TEST	Nov 10, 1988	Substantially Equivalent	Hygeia Sciences
K882896	ONE-STEP HCG	Oct 31, 1988	Substantially Equivalent	Wampole Laboratories
K882895	MODIFIED BETA QUIK STAT EIA KIT	Oct 12, 1988	Substantially Equivalent	Pacific Biotech, Inc.
K883235	RAPIDTEST-HCG (TM)	Sep 30, 1988	Substantially Equivalent	Synbiotics Corp.
K880678	MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY	Apr 05, 1988	Substantially Equivalent	Ventrex Laboratories, Inc.
K873986	BETA-HCG ASSAY	Feb 02, 1988	Substantially Equivalent	Schiff & Co.
K873872	HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013	Oct 28, 1987	Substantially Equivalent	Medix Biotech, Inc.
K862108	ENZYMUN-TEST HCG	Aug 19, 1986	Substantially Equivalent	Boehringer Mannheim Corp.