Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DLJ · Predicate Candidate Screening
123 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
102 days90th percentile
123clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL | Randox Laboratories, Ltd. | 2013-08-08 | 27 | 0 |
| K091617 | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | Thermo Fisher Scientific | 2009-07-17 | 44 | 0 |
| K082030 | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | Siemens Healthcare Diagnostics, Inc. | 2008-08-22 | 36 | 0 |
| K062182 | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | Dade Behring, Inc. | 2006-09-14 | 45 | 0 |
| K062199 | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430 | Dade Behring, Inc. | 2006-09-06 | 36 | 0 |
| K061503 | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) | Dade Behring, Inc. | 2006-06-22 | 21 | 0 |
| K060503 | DIMENSION TACR CALIBRATOR, MODEL DC107 | Dade Behring, Inc. | 2006-05-18 | 83 | 0 |
| K053108 | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL | Dade Behring, Inc. | 2006-02-16 | 104 | 0 |
| K052015 | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # | Dade Behring, Inc. | 2005-09-12 | 48 | 0 |
| K033601 | LABONE MICRO-PLATE COTININE EIA | Labone, Inc. | 2004-02-10 | 88 | 0 |
| K033246 | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS | Roche Diagnostics Corp. | 2003-12-02 | 56 | 0 |
| K033165 | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE A | Roche Diagnostics Corp. | 2003-10-14 | 14 | 0 |
| K023780 | DRI PRIMIDONE CALIBRATORS | Microgenics Corp. | 2003-02-10 | 90 | 0 |
| K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-12-16 | 74 | 0 |
| K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-06-18 | 43 | 1 |
| K020845 | EMIT 2000 VANCOMYCIN CALIBRATORS | Dade Behring, Inc. | 2002-05-08 | 54 | 0 |
| K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-04-03 | 27 | 0 |
| K012109 | DRI ECSTASY URINE CALIBRATORS | Microgenics Corp. | 2001-08-27 | 52 | 0 |
| K011112 | CYCLOSPORINE CALIBRATOR | Dade Behring, Inc. | 2001-07-17 | 97 | 0 |
| K993473 | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 | Beckman Coulter, Inc. | 1999-11-26 | 43 | 0 |
| K993022 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS | Beckman Coulter, Inc. | 1999-11-09 | 61 | 0 |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Roche Diagnostic Systems, Inc. | 1998-12-15 | 63 | 0 |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Roche Diagnostic Systems, Inc. | 1998-12-15 | 63 | 0 |
| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1998-07-22 | 50 | 0 |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-06 | 49 | 0 |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | Diagnostic Reagents, Inc. | 1997-08-28 | 28 | 0 |
| K972433 | CEDIA DIGOXIN CALIBRATORS | Boehringer Mannheim Corp. | 1997-07-24 | 24 | 0 |
| K970509 | INNOFLOUR CALIBRATOR REAGENT SET | Oxis Intl., Inc. | 1997-05-12 | 90 | 0 |
| K962280 | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR | Roche Diagnostic Systems, Inc. | 1996-08-16 | 64 | 0 |
| K961726 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 | Roche Diagnostic Systems, Inc. | 1996-07-11 | 69 | 0 |
| K940048 | STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION | Solarcare Technologies Corp,Inc. | 1996-03-19 | 804 | 0 |
| K955813 | CEDIA DAU LSD CALBIRATORS | Microgenics Corp. | 1996-02-09 | 45 | 0 |
| K951153 | CEDIA DAU PPX/METH CALIBRATOR | Microgenics Corp. | 1995-04-21 | 38 | 0 |
| K945338 | THEOPHYLLINE CALIBRATORS | Diagnostic Reagents, Inc. | 1995-01-17 | 77 | 0 |
| K945316 | PHENOBARBITAL CALIBRATORS | Diagnostic Reagents, Inc. | 1995-01-04 | 64 | 0 |
| K945337 | PHENYTOIN CALIBRATORS | Diagnostic Reagents, Inc. | 1994-12-07 | 36 | 0 |
| K935795 | CEDIA DAU THC CALIBRATORS | Microgenics Corp. | 1994-04-06 | 120 | 0 |
| K932548 | ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS | Roche Diagnostic Systems, Inc. | 1993-12-29 | 217 | 0 |
| K934144 | DUPONT ACA URINE METHADONE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1993-11-09 | 76 | 0 |
| K933279 | ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR | Roche Diagnostic Systems, Inc. | 1993-08-09 | 34 | 0 |
| K931506 | URINE CALIBRATOR AND CONTROL | Diagnostic Reagents, Inc. | 1993-07-28 | 125 | 0 |
| K923386 | THC URINE CALIBRATORS | Diagnostic Reagents, Inc. | 1992-09-14 | 75 | 0 |
| K920749 | THC URINE CALIBRATORS | Diagnostic Reagents, Inc. | 1992-03-18 | 28 | 0 |
| K915464 | DIGITOXIN FPIA CALIBRATOR SET | Sigma Diagnostics, Inc. | 1992-01-15 | 44 | 0 |
| K913186 | INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET | Intl. Bioclinical, Inc. | 1991-08-30 | 43 | 0 |
| K912048 | ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS | Roche Diagnostic Systems, Inc. | 1991-07-26 | 78 | 0 |
| K911466 | INNOFLUOR VALPROIC ACID CALIBRATOR SET | Intl. Bioclinical, Inc. | 1991-05-23 | 50 | 0 |
| K910086 | ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS | Roche Diagnostic Systems, Inc. | 1991-01-17 | 9 | 0 |
| K904569 | EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS | Syva Co. | 1990-12-26 | 78 | 0 |
| K904307 | DUPONT SALICYLATE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1990-11-06 | 48 | 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