Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DAP — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
124 daysmedian FDA review time
276 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | 2017-11-22 | 61 | 0 |
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | 2016-12-10 | 124 | 2 |
| K160885 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2016-10-27 | 210 | 0 |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2015-07-06 | 28 | 0 |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | 2014-09-03 | 124 | 1 |
| K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | bioMerieux, Inc. | 2012-07-31 | 307 | 1 |
| K110303 | STRATUS CS ACUTE CARE D-DIMER | Siemens Healthcare Diagnostics | 2011-05-16 | 104 | 1 |
| K093626 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2010-11-29 | 370 | 0 |
| K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | Instrumentation Laboratory CO | 2010-02-05 | 367 | 0 |
| K091916 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2009-10-29 | 121 | 0 |
| K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | Siemens Healthcare Diagnostics | 2008-10-24 | 127 | 0 |
| K073042 | HEMOSIL D-DIMER | Instrumentation Laboratory | 2008-07-31 | 276 | 0 |
| K080069 | DIMERTEST | American Diagnostica, Inc. | 2008-02-13 | 34 | 0 |
| K070927 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2007-09-17 | 167 | 0 |
| K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | Dade Behring, Inc. | 2007-03-23 | 136 | 1 |
| K051597 | STRATUS CS D-DIMER | Dade Behring, Inc. | 2005-08-17 | 62 | 1 |
| K050544 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2005-04-26 | 55 | 0 |
| K050278 | HEMOSIL D-DIMER | Instrumentation Laboratory CO | 2005-03-10 | 31 | 0 |
| K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | Biosite Incorporated | 2004-12-07 | 67 | 0 |
| K033491 | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOS | Roche Diagnostics Corp. | 2004-09-01 | 302 | 0 |
| K041438 | ADVANCED D-DIMER ASSAY | Dade Behring, Inc. | 2004-08-11 | 71 | 2 |
| K040437 | TRIAGE PROFILER S.O.B. PANEL | Biosite Incorporated | 2004-06-25 | 127 | 0 |
| K040882 | VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 | bioMerieux, Inc. | 2004-06-10 | 66 | 0 |
| K032419 | QUANTEX D-DIMER | Instrumentation Laboratory CO | 2003-10-24 | 80 | 0 |
| K030328 | VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 | bioMerieux, Inc. | 2003-09-02 | 214 | 0 |
| K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; | Kamiya Biomedical Co. | 2003-06-27 | 114 | 0 |
| K022976 | STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS | Dade Behring, Inc. | 2003-01-16 | 132 | 1 |
| K022977 | STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C | Dade Behring, Inc. | 2002-11-27 | 82 | 0 |
| K020810 | VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 | bioMerieux, Inc. | 2002-10-03 | 204 | 0 |
| K012755 | AUTODIMER ASSAY MODEL # 1431 | Xtrana, Inc. | 2002-03-15 | 211 | 0 |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | Sigma Diagnostics, Inc. | 2001-12-26 | 63 | 0 |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | Sigma Diagnostics, Inc. | 2001-11-15 | 22 | 0 |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | Sigma Diagnostics, Inc. | 2001-11-15 | 22 | 0 |
| K002948 | K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT | Kamiya Biomedical Co. | 2001-05-18 | 239 | 0 |
| K002706 | ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE | Roche Diagnostics Corp. | 2001-03-16 | 198 | 0 |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Sigma Diagnostics, Inc. | 2001-03-15 | 148 | 0 |
| K002642 | MINIQUANT D-DIMER, MODEL 1447 | Biopool Intl., Inc. | 2001-02-05 | 165 | 0 |
| K000492 | MDA D-DIMER | Organon Teknika Corp. | 2000-06-07 | 113 | 0 |
| K992957 | ADVANCED D-DIMER | Dade Behring, Inc. | 2000-01-28 | 148 | 0 |
| K974596 | DIMERTEST LATEX ASSAY | Agen Biomedical , Ltd. | 1998-05-26 | 168 | 0 |
| K974776 | MDA D-DIMER | Organon Teknika Corp. | 1998-04-16 | 115 | 0 |
| K973819 | VIDAS D-DIMER (DD) ASSAY | Biomerieux Vitek, Inc. | 1998-03-10 | 154 | 0 |
| K972696 | IL TEST D-DIMER | Instrumentation Laboratory CO | 1997-11-04 | 109 | 0 |
| K964728 | STA-LIATEST D-DI TEST KIT | American Bioproducts Co. | 1997-06-26 | 213 | 1 |
| K964718 | STA D-DI CALIBRATOR KIT | American Bioproducts Co. | 1997-05-23 | 179 | 0 |
| K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS | More Diagnostics | 1995-06-15 | 331 | 0 |
| K943787 | AURATEK FDP | Organon Teknika Corp. | 1994-09-20 | 48 | 0 |
| K932657 | FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 | More Diagnostics | 1993-11-02 | 153 | 0 |
| K915698 | FIBRINOSTIKA TDP MICROELISA SYSTEM | Organon Teknika Corp. | 1992-08-05 | 226 | 0 |
| K920943 | FDP PLASMA TEST KIT | American Bioproducts Co. | 1992-07-13 | 137 | 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