Product code JHI— Clinical Chemistry
BIONIKE A/Q PREGNANCY TEST
- Classification name
- Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Total cleared
- 375
- First cleared
- Most recent
Market context for product code JHI
FDA has cleared devices under product code JHI between 1976 and 2024, filed by 155 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2022
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2010
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code JHI
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JHI
1–100 of 375- K241919 — Innovita HCG Pregnancy Rapid Combo Test
- K203272 — Alltest Pregnancy Rapid Combo Test Cassette
- K172322 — Atellica IM Total hCG (ThCG)
- K172257 — 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)
- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
- K130456 — WUNDER PREGNANCY TEST
- K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST
- K131166 — SOFIA(R) HCG FIA
- K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
- K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
- K112315 — HOME PREGNANCY TEST
- K102175 — RAPIDVUE HCG TEST
- K072264 — FASTPACK HCG IMMUNOASSAY
- K070921 — BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
- K071030 — BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
- K061257 — DBEST HCG PANEL TEST KIT
- K062361 — INNOVACON HCG UKTRA TEST DEVICE
- K050955 — LIFESIGN DXPRESS, MODEL LSR2000
- K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
- K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
- K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
- K043385 — OSOM HCG COMBO TEST
- K041946 — ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
- K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
- K033297 — ZAP HCG TEST, MODEL 8001
- K032563 — CLINITEST HCG PREGNANCY TEST
- K032987 — ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
- K031445 — MAINLINE MAXIE HCG URINE PREGNANCY TEST
- K031048 — CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
- K023823 — EASYCUP
- K030430 — POLY STAT SERUM/URINE HCG TEST
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST
- K023480 — ACCESS TOTAL BHCG
- K022683 — SAS BLOOD/SERUM/URINE/URINE HCG
- K021386 — POLY STAT HCG DIPSTICK TEST
- K020968 — LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
- K020378 — QUPID PLUS E.R.
- K020439 — STATUS HCG SERUM/URINE
- K020799 — QUICKVUE ONE-STEP HCG-URINE
- K020801 — QUICKVUE ONE-STEP HCG-COMBO
- K020438 — SAS VALUE HCG
- K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
- K013702 — VICTORCH HCG TEST STRIP
- K012559 — POLY STAT HCG TEST
- K013194 — UNIMARK HCG COMBO PREGNANCY TEST
- K012284 — WH ACCU TEST PREGNANCY TEST
- K011550 — HCG STAT PAK ULTRA-FAST
- K010522 — SUREVUE URINE HCG
- K010593 — SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
- K003856 — EZ-HCG URINE(PREGNANCY TEST)
- K001215 — DBEST HCG 2 IU/ML TEST KIT
- K994227 — ADVANTAGE HCG TEST (URINE/SERUM)
- K993703 — CLEARVIEW EASY HCG PREGNANCY TEST
- K993203 — ACON ONE STEP PREGNANCY TEST STRIP (URINE)
- K993317 — ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
- K992915 — ONE-STEP DOUBLE-CHEK PREGNANCY TEST
- K992695 — INSURE PRO TEST
- K993065 — ACON COMBO PREGNANCY
- K992397 — ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
- K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
- K990684 — MODIFICATION OF SAS SERUM/URINE HCG
- K990741 — SAS ONE-STEP PREGNANCY
- K991095 — QUICKCARD HCG COMBO TEST, MODEL #9014
- K991067 — MODIFICATION OF: DAVIDSTRIP HCG
- K990578 — OSOM CARD II HCG-URINE TEST, MODEL 102
- K984076 — INSTANT-VIEW PREGNANCY URINE TEST
- K984077 — INSTANT-VIEW PREGNANCY COMBO TEST
- K984079 — INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
- K984080 — INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
- K981444 — BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
- K981443 — BIOSIGN HCG I - ONE STEP PREGNANCY TEST
- K981838 — ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
- K981770 — RAPIDHCG PREGNANCY TEST
- K981512 — ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
- K980736 — ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
- K981165 — AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
- K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST
- K980896 — QUICKCARD PRO HCG TEST, MODEL 9008
- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
- K974009 — PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
- K980531 — AIMSTEP PREGNANCY
- K980205 — SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
- K974615 — QUICKSTICK PRO HCG TEST
- K974851 — SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
- K974159 — OSOM HCG-URINE TEST MODEL 101
- K974052 — QUICKVUE SEMI-Q HCG-COMBO
- K973957 — DBEST ONE-STEP HCG SERUM/URINE TEST
- K973841 — QUICKVUE ONE-STEP HCG-COMBO
- K973858 — CARDS Q.S. HCG SERUM/URINE; CONCISE PERFORMANCE PLUS HCG-COMBO
- K973879 — OSOM CARD HCG-URINE TEST
- K972742 — QUICKVUE ONE-STEP HCG-URINE
- K972748 — CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
- K971886 — ACCUTEST HCG-URINE
- K971122 — ACCULINE PREGNANCY TEST
- K971209 — CLINITEK HCG TEST STRIPS
- K970424 — EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
- K964633 — ACCUPACK PREGNANCY TEST
- K965116 — ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
- K965250 — SAS SERUM/URINE HCG
Data sourced from openFDA. This site is unofficial and independent of the FDA.