Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JHI — Predicate Candidate Screening
375 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
125 days90th percentile
375clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 | 32 | 0 |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 | 451 | 0 |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 | 240 | 0 |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), T | True Diagnostics, Inc. | 2017-12-22 | 149 | 0 |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, A | Assure Tech. Co., Ltd. | 2016-02-24 | 153 | 0 |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | 2014-04-08 | 410 | 0 |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | 2014-01-09 | 121 | 0 |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | 2013-08-02 | 100 | 0 |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE C | Chemtron Biotech, Inc. | 2013-05-30 | 168 | 0 |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. | 2012-07-17 | 361 | 0 |
| K112315 | HOME PREGNANCY TEST | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 | 256 | 0 |
| K102175 | RAPIDVUE HCG TEST | Quidel Corporation | 2010-08-25 | 23 | 0 |
| K072264 | FASTPACK HCG IMMUNOASSAY | Qualigen, Inc. | 2007-12-06 | 113 | 0 |
| K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TES | Applied Dna Technologies, Inc. | 2007-06-29 | 79 | 0 |
| K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08 | Applied Dna Technologies, Inc. | 2007-06-29 | 88 | 0 |
| K061257 | DBEST HCG PANEL TEST KIT | Ameritek USA, Inc. | 2007-05-04 | 365 | 0 |
| K062361 | INNOVACON HCG UKTRA TEST DEVICE | Innovacon, Inc. | 2006-10-23 | 70 | 4 |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | Princeton BioMeditech Corp. | 2006-01-23 | 283 | 0 |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | Ind Diagnostic, Inc. | 2005-12-16 | 79 | 0 |
| K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | W.H.P.M., Inc. | 2005-08-22 | 46 | 0 |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | Ind Diagnostic, Inc. | 2005-05-16 | 56 | 3 |
| K043385 | OSOM HCG COMBO TEST | Genzyme Diagnostics | 2005-04-12 | 124 | 0 |
| K041946 | ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE | ACON Laboratories, Inc. | 2004-08-16 | 28 | 0 |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | Immunostics Inc., | 2004-08-11 | 47 | 0 |
| K033297 | ZAP HCG TEST, MODEL 8001 | Zbx Corporation | 2004-03-18 | 156 | 0 |
| K032563 | CLINITEST HCG PREGNANCY TEST | Bayer Healthcare, LLC | 2003-12-23 | 125 | 2 |
| K032987 | ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, | Unotech Diagnostics, Inc. | 2003-11-17 | 54 | 0 |
| K031445 | MAINLINE MAXIE HCG URINE PREGNANCY TEST | Mainline Technology, Inc. | 2003-07-01 | 55 | 0 |
| K031048 | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PL | Access Bio Incorporate | 2003-06-16 | 75 | 0 |
| K023823 | EASYCUP | Zer Hitech | 2003-05-22 | 188 | 0 |
| K030430 | POLY STAT SERUM/URINE HCG TEST | Alidex, Inc. | 2003-04-18 | 67 | 0 |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | Bayer Corp. | 2003-02-11 | 77 | 0 |
| K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST | Genzyme Corp. | 2003-01-16 | 86 | 0 |
| K023480 | ACCESS TOTAL BHCG | Beckman Coulter, Inc. | 2002-12-20 | 64 | 1 |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | Sa Scientific, Inc. | 2002-12-16 | 126 | 0 |
| K021386 | POLY STAT HCG DIPSTICK TEST | Alidex, Inc. | 2002-08-05 | 95 | 0 |
| K020968 | LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD | Pan Probe Biotech, Inc. | 2002-07-15 | 111 | 0 |
| K020378 | QUPID PLUS E.R. | Stanbio Laboratory | 2002-06-21 | 136 | 0 |
| K020439 | STATUS HCG SERUM/URINE | Princeton BioMeditech Corp. | 2002-05-23 | 101 | 0 |
| K020801 | QUICKVUE ONE-STEP HCG-COMBO | Quidel Corp. | 2002-05-17 | 66 | 0 |
| K020799 | QUICKVUE ONE-STEP HCG-URINE | Quidel Corp. | 2002-05-17 | 66 | 1 |
| K020438 | SAS VALUE HCG | Sa Scientific, Inc. | 2002-03-08 | 25 | 0 |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | Diagnostic Systems Laboratories, Inc. | 2002-03-01 | 45 | 0 |
| K013702 | VICTORCH HCG TEST STRIP | Victorch Meditek, Inc. | 2001-12-27 | 49 | 0 |
| K012559 | POLY STAT HCG TEST | Bion Diagnostic Sciences | 2001-10-16 | 69 | 0 |
| K013194 | UNIMARK HCG COMBO PREGNANCY TEST | Biotech Atlantic, Inc. | 2001-10-10 | 15 | 0 |
| K012284 | WH ACCU TEST PREGNANCY TEST | W.H.P.M., Inc. | 2001-08-28 | 39 | 0 |
| K011550 | HCG STAT PAK ULTRA-FAST | Chembio Diagnostic Systems, Inc. | 2001-08-14 | 88 | 0 |
| K010522 | SUREVUE URINE HCG | Sa Scientific, Inc. | 2001-07-31 | 159 | 0 |
| K010593 | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT | Sa Scientific, Inc. | 2001-04-05 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda