Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DKB — Predicate Candidate Screening
94 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
136 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | Roche Diagnostics Operations (Rdo) | 2014-11-25 | 132 | 0 |
| K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | Lin-Zhi International, Inc. | 2014-02-21 | 79 | 0 |
| K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QM | Microgenics Corporation | 2012-12-13 | 260 | 0 |
| K092266 | RANDOX METHAMPHETAMINE ASSAY | Randox Laboratories, Ltd. | 2011-05-09 | 650 | 0 |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K090939 | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND | Roche Diagnostics | 2009-06-18 | 76 | 0 |
| K090900 | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | Siemens Healthcare Diagnostics | 2009-06-01 | 61 | 0 |
| K062162 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - | Dade Behring, Inc. | 2006-09-14 | 48 | 0 |
| K062121 | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420 | Dade Behring, Inc. | 2006-08-25 | 31 | 0 |
| K060645 | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALI | Roche Diagnostics Corp. | 2006-05-30 | 81 | 0 |
| K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTRO | Lin-Zhi International, Inc. | 2005-06-24 | 57 | 3 |
| K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | Maine Standards Co. | 2004-02-27 | 74 | 0 |
| K033306 | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATO | Roche Diagnostics Corp. | 2003-12-15 | 62 | 0 |
| K032574 | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | Dade Behring, Inc. | 2003-10-06 | 47 | 0 |
| K031856 | PRECISET TDM I AND PRECISET TDM II CALIBRATORS | Roche Diagnostics Corp. | 2003-08-06 | 51 | 2 |
| K031775 | PRECISET DAT PLUS I CALIBRATORS | Roche Diagnostics Corp. | 2003-08-05 | 56 | 0 |
| K021393 | PRECISET DAT PLUS | Quantimetrix Corp. | 2002-06-13 | 42 | 0 |
| K013959 | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR | Bayer Diagnostics Corp. | 2002-01-29 | 60 | 0 |
| K012318 | RANDOX THERAPEUTIC DRUG CALIBRATOR | Randox Laboratories, Ltd. | 2001-09-12 | 51 | 0 |
| K993954 | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATO | Beckman Coulter, Inc. | 2000-01-11 | 50 | 0 |
| K993755 | EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, | Syva Co. | 1999-12-21 | 46 | 0 |
| K990255 | DIMENSION DRUG CALIBRATOR II, MODEL DC49B | Dade Behring, Inc. | 1999-02-16 | 20 | 0 |
| K983747 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II | Beckman Coulter, Inc. | 1998-12-30 | 68 | 0 |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | Diagnostic Reagents, Inc. | 1998-11-05 | 57 | 0 |
| K983209 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I | Beckman Coulter, Inc. | 1998-11-04 | 51 | 0 |
| K982871 | DRUG CALIBRATOR II | Dade Behring, Inc. | 1998-10-13 | 60 | 0 |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | Beckman Instruments, Inc. | 1998-05-08 | 21 | 0 |
| K980853 | CEDIA DAU MULTI-DRUG CALIBRATORS | Boehringer Mannheim Corp. | 1998-04-21 | 47 | 0 |
| K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN | Consolidated Technologies, Inc. | 1998-01-22 | 37 | 0 |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 | Behring Diagnostics, Inc. | 1997-06-25 | 55 | 0 |
| K971287 | SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS | Beckman Instruments, Inc. | 1997-05-08 | 31 | 0 |
| K962817 | DRUG CALIBRATOR II | Dade Intl., Inc. | 1996-09-16 | 59 | 0 |
| K963191 | CEDIA ANTIBIOTIC TDM MULTI-CALS | Boehringer Mannheim Corp. | 1996-09-10 | 26 | 0 |
| K961273 | AED CALIBRATORS | Diagnostic Reagents, Inc. | 1996-05-15 | 43 | 0 |
| K961372 | SERUM TOX CALIBRATOR | Diagnostic Reagents, Inc. | 1996-05-01 | 22 | 0 |
| K954608 | CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH | Boehringer Mannheim Corp. | 1995-12-26 | 83 | 0 |
| K935192 | EMIT IIC CALIBRATORS | Syva Co. | 1995-03-24 | 514 | 0 |
| K950139 | DRUGS OF ABUSE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1995-02-22 | 40 | 0 |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Medi-Tech, Inc. | 1994-12-13 | 43 | 0 |
| K942048 | ROCHE AMMONIA (VARIOUS) | Roche Diagnostic Systems, Inc. | 1994-10-04 | 159 | 0 |
| K940935 | URINE CALIBRATOR | Diagnostic Reagents, Inc. | 1994-07-06 | 131 | 0 |
| K935793 | CEDIA DAU NEGATIVE CALIBRATOR | Microgenics Corp. | 1994-03-14 | 97 | 0 |
| K936028 | CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB | Microgenics Corp. | 1994-03-14 | 87 | 0 |
| K935101 | URINE CALIBRATORS AND CONTROLS MODIFICATION | Diagnostic Reagents, Inc. | 1994-01-27 | 99 | 0 |
| K935794 | CEDIA DAU 4-DRUG CUTOFF CALIBRATOR | Microgenics Corp. | 1994-01-25 | 49 | 0 |
| K935792 | CEDIA DAU 5-DRUG CALIBRATORS | Microgenics Corp. | 1994-01-25 | 49 | 0 |
| K935550 | ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIB | Roche Diagnostic Systems, Inc. | 1994-01-03 | 47 | 0 |
| K931124 | ABUSCREEN ONLINE(R) CALIBRATORS | Roche Diagnostic Systems, Inc. | 1993-08-03 | 152 | 0 |
| K932753 | ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS | Roche Diagnostic Systems, Inc. | 1993-07-22 | 55 | 0 |
| K932754 | ABUSCREEN CALIBRATION STANDARD | Roche Diagnostic Systems, Inc. | 1993-07-22 | 55 | 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