Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDZ · Predicate Candidate Screening
89 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
248 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026-04-15 | 230 | 0 |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Limited | 2024-10-23 | 209 | 0 |
| K233480 | Access SHBG | Beckman Coulter, Inc. | 2024-02-08 | 105 | 0 |
| K223405 | Access Testosterone | Beckman Coulter, Inc. | 2023-01-13 | 65 | 1 |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022-05-06 | 338 | 0 |
| K201908 | LIAISON Testosterone xt | DiaSorin, Inc. | 2020-10-15 | 98 | 0 |
| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | 2019-12-20 | 214 | 0 |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 | 79 | 0 |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | 2019-06-17 | 143 | 0 |
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. | 2019-01-29 | 138 | 1 |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018-07-20 | 101 | 0 |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | 2016-10-14 | 304 | 0 |
| K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testoster | Siemens Healthcare Diagnostics, Inc. | 2016-06-29 | 348 | 0 |
| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartrid | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 | 248 | 0 |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | 2016-02-11 | 190 | 0 |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Laboratories | 2015-12-17 | 136 | 0 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | 2015-07-02 | 248 | 0 |
| K133491 | ADVIA CENTAUR TESTOSTERONE (TSTO) | Siemens Healthcare Diagnostics, Inc. | 2014-02-21 | 100 | 0 |
| K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | DiaSorin, Inc. | 2013-01-25 | 135 | 0 |
| K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MA | Abbott Laboratories | 2012-09-11 | 252 | 0 |
| K101388 | FASTPACK TESTO IMMUNOASSAY | Qualigen, Inc. | 2011-02-18 | 277 | 0 |
| K102814 | ELECYSYS SHBG | Roche Diagnostics | 2011-01-20 | 114 | 0 |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Roche Diagnostics Corp. | 2010-04-23 | 171 | 0 |
| K091867 | ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND M | Siemens Healthcare Diagnostics | 2010-01-14 | 205 | 0 |
| K083867 | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORM | Beckman Coulter, Inc. | 2009-08-27 | 241 | 1 |
| K060818 | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, A | Biokit, S.A. | 2007-01-23 | 302 | 1 |
| K052649 | DRG SLV TESTOSTERONE ELISA TEST | Drg Intl., Inc. | 2006-01-27 | 123 | 1 |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY ( | Axis-Shield Diagnostics, Ltd. | 2004-09-29 | 82 | 0 |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 | Diagnostic Products Corp. | 2003-10-10 | 25 | 2 |
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | Diagnostics Biochem Canada, Inc. | 2003-08-18 | 161 | 0 |
| K031717 | ELECSYS SHBG IMMUNOASSAY | Roche Diagnostics Corp. | 2003-08-05 | 63 | 0 |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Tosoh Medics, Inc. | 2002-12-17 | 91 | 1 |
| K021972 | FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY | Qualigen, Inc. | 2002-08-21 | 65 | 1 |
| K021326 | VIDAS TESTOSTERONE (TES), MODEL 30 418 | bioMerieux, Inc. | 2002-07-18 | 83 | 1 |
| K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | Diagnostics Biochem Canada, Inc. | 2002-02-08 | 53 | 0 |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | Biocheck, Inc. | 2000-10-02 | 67 | 0 |
| K001935 | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASS | Beckman Coulter, Inc. | 2000-08-22 | 57 | 0 |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | Diagnostic Systems Laboratories, Inc. | 2000-05-18 | 44 | 0 |
| K000043 | DRG AURICA ELISA TESTOSTERONE KIT | Drg Intl., Inc. | 2000-04-17 | 102 | 0 |
| K983212 | ABBOTT ARCHITECT TESTOSTERONE | Abbott Laboratories | 1998-11-18 | 65 | 12 |
| K973900 | TESTOTERONE ELISA | Kmi Diagnostics, Inc. | 1998-02-24 | 133 | 0 |
| K971823 | ACTIVE TESTOSTERONE EIA (DSL-10-4000) | Diagnostic Systems Laboratories, Inc. | 1997-06-16 | 31 | 0 |
| K964889 | ELECSYS TESTOSTERONE ASSAY | Boehringer Mannheim Corp. | 1997-03-18 | 102 | 0 |
| K963080 | TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VI | Bayer Corp. | 1996-09-27 | 50 | 0 |
| K955102 | BIODATA TESTOSTERONE MAIA KIT | Biochem Immunosystems (U.S.), Inc. | 1996-06-24 | 229 | 0 |
| K955870 | IMMULITE TOTAL TESTOSTERONE | Diagnostic Products Corp. | 1996-02-06 | 40 | 0 |
| K955440 | IMMULITE SHBG (MODIFICATION) | Diagnostic Products Corp. | 1995-12-21 | 59 | 1 |
| K951685 | AURAFLEX TESTOSTERONE CALIBRATOR PACK | Organon Teknika Corp. | 1995-11-14 | 218 | 0 |
| K952281 | ACTIVE FREE TESTOSTERONE RIA | Diagnostic Systems Laboratories, Inc. | 1995-07-17 | 62 | 0 |
| K941797 | IMMULITE SHBG | Diagnostic Products Corp. | 1994-10-31 | 202 | 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