DHA · Class II · 21 CFR 862.1155

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, Germaine Laboratories, Inc. and Dade Behring, Inc..

72
Total
72
Cleared
117d
Avg days
1986
Since
72 devices
25–48 of 72
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
K022681
Azog, Inc.
Chemistry · 81d
Cleared Jan 22, 2002
AIMSTEP PREGNANCY
K013857
Germaine Laboratories, Inc.
Chemistry · 62d
Cleared Dec 27, 2001
VICTORCH MEDITEK'S HCG TEST CARD
K013678
Victorch Meditek, Inc.
Chemistry · 50d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
K003696
Dade Behring, Inc.
Chemistry · 56d
Cleared Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
K003178
Roche Diagnostics Corp.
Chemistry · 64d
Cleared Aug 22, 2000
ELECSYS HCG TEST SYSTEM
K002148
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Jun 16, 2000
ABSOLUTE HCG PREGNANCY TEST
K000844
Mizuho USA, Inc.
Chemistry · 93d
Cleared Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085
Diagnostic Products Corp.
Chemistry · 56d
Cleared Sep 17, 1999
DRX QT. HCG
K991532
Metrika, Inc.
Chemistry · 137d
Cleared May 28, 1999
INSURE PREGNANCY TEST
K991515
Inbios Intl., Inc.
Chemistry · 28d
Cleared Feb 26, 1999
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
K990222
Diagnostic Products Corp.
Chemistry · 32d
Cleared Dec 01, 1998
ABBOTT ARCHEITECT TOTAL B-HCG
K983424
Abbott Laboratories
Chemistry · 63d
Cleared Jan 02, 1998
AIMSTICK PBD PREGNANCY
K974368
Germaine Laboratories, Inc.
Chemistry · 43d
Cleared Jan 02, 1998
AIMSTICK PBD COMBO PREGNANCY
K974512
Germaine Laboratories, Inc.
Chemistry · 32d
Cleared Dec 24, 1997
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
K974425
Princeton BioMeditech Corp.
Chemistry · 30d
Cleared Dec 19, 1997
MIDSTREAM HOME REGNANCY TEST
K973825
Germaine Laboratories, Inc.
Chemistry · 73d
Cleared Apr 14, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
K970894
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 34d
Cleared Mar 10, 1997
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387
Dade Chemistry Systems, Inc.
Chemistry · 35d
Cleared Aug 21, 1996
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
K961792
Biocircuits Corp.
Chemistry · 104d
Cleared Jun 12, 1996
ELECSYS HCG ASSAY
K961487
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Jun 03, 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
K961351
Bayer Corp.
Chemistry · 59d
Cleared May 02, 1996
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
K955707
Excel Scientific, Inc.
Chemistry · 139d
Cleared Jul 17, 1995
AMERLITE HCG-60 ASSAY
K952283
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 62d
Cleared Mar 20, 1995
AURAFLEX HCG
K945331
Organon Teknika Corp.
Chemistry · 139d