FDA Product Code JHI: Visual, Pregnancy Hcg, Prescription Use
Leading manufacturers include Quidel Corp., Abbott Laboratories and Hybritech, Inc..
376
Total
376
Cleared
70d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
77d avg (recent)
FDA 510(k) Cleared Visual, Pregnancy Hcg, Prescription Use Devices (Product Code JHI)
376 devices
Cleared
Sep 22, 2026
Instant-View® hCG Combo II Cassette Test
Alfa Scientific Designs, Inc.
Chemistry
77d
Cleared
Aug 02, 2024
Innovita HCG Pregnancy Rapid Combo Test
Innovita (Tangshan) Biological Technology Co., Ltd.
Chemistry
32d
Cleared
Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
Hangzhou AllTest Biotech Co., Ltd.
Chemistry
451d
Cleared
Mar 29, 2018
Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics, Inc.
Chemistry
240d
Cleared
Dec 22, 2017
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
True Diagnostics, Inc.
Chemistry
149d
Cleared
Feb 24, 2016
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
Assure Tech. Co., Ltd.
Chemistry
153d
Cleared
Apr 08, 2014
WUNDER PREGNANCY TEST
James Nguyen
Chemistry
410d
Cleared
Jan 09, 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
Polymed Therapeutics, Inc.
Chemistry
121d
Cleared
Aug 02, 2013
SOFIA(R) HCG FIA
Quidel Corp.
Chemistry
100d
Cleared
May 30, 2013
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
Chemtron Biotech, Inc.
Chemistry
168d
Cleared
Jul 17, 2012
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
Polymed Therapeutics, Inc.
Chemistry
361d
Cleared
Apr 23, 2012
HOME PREGNANCY TEST
Newscen Coast Bio-Pharmaceutical Co., Ltd.
Chemistry
256d
Cleared
Aug 25, 2010
RAPIDVUE HCG TEST
Quidel Corporation
Chemistry
23d
Cleared
Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
Qualigen, Inc.
Chemistry
113d
Cleared
Jun 29, 2007
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
Applied Dna Technologies, Inc.
Chemistry
88d
Cleared
Jun 29, 2007
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
Applied Dna Technologies, Inc.
Chemistry
79d
Cleared
May 04, 2007
DBEST HCG PANEL TEST KIT
Ameritek USA, Inc.
Chemistry
365d
Cleared
Oct 23, 2006
INNOVACON HCG UKTRA TEST DEVICE
Innovacon, Inc.
Chemistry
70d
Cleared
Jan 23, 2006
LIFESIGN DXPRESS, MODEL LSR2000
Princeton BioMeditech Corp.
Chemistry
283d
Cleared
Dec 16, 2005
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
Ind Diagnostic, Inc.
Chemistry
79d
Cleared
Aug 22, 2005
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
W.H.P.M., Inc.
Chemistry
46d
Cleared
May 16, 2005
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
Ind Diagnostic, Inc.
Chemistry
56d
Cleared
Apr 12, 2005
OSOM HCG COMBO TEST
Genzyme Diagnostics
Chemistry
124d
Cleared
Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
ACON Laboratories, Inc.
Chemistry
28d
About Product Code JHI - Regulatory Context
510(k) Submission Activity
376 total 510(k) submissions under product code JHI since 1976, with 376 receiving FDA clearance (average review time: 70 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - JHI Product Code
FDA review times for JHI submissions have been consistent, averaging 77 days recently vs 70 days historically.
JHI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →