Atlas FDA

DIF

202 FDA 510(k) clearances · Product code

37 daysmedian time to decision
110 days90th percentile
202clearances measured

FDA profile

Official device name
Drug Mixture Control Materials
Device class
Class I (low risk)
Regulation
21 CFR 862.3280
Medical specialty
Clinical Toxicology
Adverse events (MAUDE)
2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series (K153474)Biochemical Diagnostics, Inc.2016-02-23
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ (K132688)Biochemical Diagnostics, Inc.2013-12-16
MULTICHEM WBT (K132174)Techno-Path Manufacturing , Ltd.2013-09-20
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (K121122)Biochemical Diagnostic, Inc.2012-07-03
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (K121143)Bio-Rad Laboratories2012-05-18
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK (K120504)Bio-Rad Laboratories, Inc.2012-03-27
THERMO SCIENTIFIC MAS R DOA TOTAL (K103656)Microgenics Corporation2011-03-24
LIQUICHEK OPIATE CONTROL (K093577)Bio-Rad Laboratories2010-03-12
MAS TOX CONTROL (K080085)Thermo Fisher Scientific2008-04-30
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183)Roche Diagnostics Corp.2008-03-25
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (K072721)Bio-Rad, Diagnostics Grp.2007-12-11
ESA LEADCARE II LEAD CONTROL (K063398)Bionostics, Inc.2006-12-05
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 (K062191)Dade Behring, Inc.2006-08-21
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (K060788)Biosite Incorporated2006-07-10
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K060417)Quantimetrix Corp.2006-03-21
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK (K052053)Bio-Rad2005-08-09
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) (K050682)Bio-Rad Laboratories, Inc.2005-04-29
TRIAGE TOX DRUG SCREEN CONTROLS (K050037)Biosite Incorporated2005-03-22
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) (K042865)Bio-Rad2004-11-24
DC-ACETA/SAL CONTROLS (K041666)Diagnostic Chemicals , Ltd.2004-08-17
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL (K041561)Bio-Rad2004-07-06
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT (K040758)Microgenics Corp.2004-05-28
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) (K033924)Bio-Rad Laboratories, Inc.2004-02-03
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 (K033366)Bio-Rad2003-12-12
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) (K033404)Bio-Rad2003-12-12
MAS PAR TDM (K032826)Medical Analysis Systems, Inc.2003-10-09
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 (K022707)Bio-Rad2002-08-22
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 (K021414)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 (K021411)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 (K021384)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 (K021415)Bio-Rad2002-05-29
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 (K012999)Biosite Incorporated2001-10-03
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 (K013002)Biosite Incorporated2001-10-03
LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL (K012907)Clinical Controls2001-09-28
LIQUICHEK TDM CONTROL (K012741)Bio-Rad2001-09-12
RANDOX HUMAN ASSSAYED DRUG CONTROL (K012319)Randox Laboratories, Ltd.2001-08-24
URINE DRUG SCREENING CONTROL (K992395)Seracare Technology1999-08-26
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV (K990377)Roche Diagnostics Corp.1999-02-26
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 (K983709)Beckman Coulter, Inc.1998-10-28
ONTRAK TESTCUP AND TESTSTIK CONTROLS (K983387)Roche Diagnostic Systems, Inc.1998-10-09
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 (K983127)Medical Analysis Systems, Inc.1998-09-14
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III (K982649)Ortho-Clinical Diagnostics, Inc.1998-08-12
AC/AD LINEARITY VERIFIERS (K982217)Sc Calibrators & Controls, LLC1998-07-02
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 (K982024)Medical Analysis Systems, Inc.1998-06-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON (K981590)Bio-Rad1998-06-10
LYPHOCHEK WHOLE BLOOD CONTROL (K980871)Bio-Rad1998-04-06
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S (K980331)More Diagnostics1998-03-16
VIGIL TDM CONTROLS (K972819)Beckman Instruments, Inc.1997-08-13
PRECINORM TDM CONTROLS (K971060)Boehringer Mannheim Corp.1997-07-07
LYPHOCHEK REMEDI CONTROL (K972174)Bio-Rad1997-06-24
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 (K971691)Bio-Rad1997-05-30
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL (K971534)Beckman1997-05-21
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) (K971058)Medical Analysis Systems, Inc.1997-04-08
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL (K970666)Bio-Rad1997-03-10
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 (K964771)Dyna-Tek Industries1997-02-04
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 (K965157)Boehringer Mannheim Corp.1997-01-17
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL (K964422)Roche Diagnostic Systems, Inc.1996-11-25
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET (K962165)Roche Diagnostic Systems, Inc.1996-06-26
U-DOA CONTROLS (K961724)Medical Diagnostic Technologies, Inc.1996-06-03
DOCUMENT TDM ULTRA ASSAYED CONTROL (K960244)Casco Standards1996-03-22
LYPHOCHEK BENZO/TCA CONTROL-SET B (K955153)Bio-Rad1996-02-05
DOCUMENT TDM ULTRA UNASSAYED CONTROL (K955155)Casco Standards1995-12-20
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL (K954799)Roche Diagnostic Systems, Inc.1995-12-13
OPUS TDM CONTROLS (K954291)Behring Diagnostics, Inc.1995-11-20
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL (K954322)Medical Analysis Systems, Inc.1995-10-11
ABUSCREEN ONLINE CONTROLS (K953739)Roche Diagnostic Systems, Inc.1995-09-20
ABUSCREEN ONLINE DRUG FREE URINE (K953845)Roche Diagnostic Systems, Inc.1995-09-20
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (K952412)Dupont Medical Products1995-06-23
ELI URINE CONTROLS (K951817)Elsohly Labs, Inc.1995-06-19
IMMUNOASSAY DRUGS OF ABUSE CONTROLS (K952056)Medi-Tech, Inc.1995-06-01
MULTI-DRUG CONTROL SET (K951135)Microgenics Corp.1995-04-13
DRUGS OF ABUSE CONTROLS (K950138)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
ABUSCREEN ONTRAK POSITIVE CONTROL (K943999)Roche Diagnostic Systems, Inc.1995-01-25
ABUSCREEN ONLINE CONTROLS (K945194)Roche Diagnostic Systems, Inc.1994-12-09
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL (K943422)Utak Lab, Inc.1994-11-02
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (K942551)Medi-Tech, Inc.1994-10-06
NIDA-5/RT, DRUG OF ABUSE CONTROLS (K942041)Meditech1994-09-14
DOA-PLUS, DRUGS OF ABUSE CONTROLS (K942257)Medical Diagnostic Technologies, Inc.1994-09-14
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (K942552)Medi-Tech, Inc.1994-09-09
ROCHE TDM CALIBRATION VERIFICATION TEST SET (K942114)Roche Diagnostic Systems, Inc.1994-09-02
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 (K940433)Medical Analysis Systems, Inc.1994-07-20
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS (K936166)Medical Analysis Systems, Inc.1994-07-13
DOA LIQUID DRUGS OF ABUSE CONTROLS (K934498)Medical Analysis Systems, Inc.1994-07-06
CEDIA DAU CONTROLS (K934650)Medical Analysis Systems, Inc.1994-04-26
DRUGS OF ABUSE CONTROLS (K935285)Medical Diagnostic Technologies, Inc.1994-03-22
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II (K935230)Syva Co.1994-01-03
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (K934062)Biotrack, Inc.1993-12-29
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS (K932549)Roche Diagnostic Systems, Inc.1993-08-26
ABUSCREEN ONLINE CONTROL (K931125)Roche Diagnostic Systems, Inc.1993-08-03
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL (K932643)Bio-Rad1993-07-08
PROCHECK(TM) BLIND PERFORMANCE SPECIMENS (K931105)Dynagen, Inc.1993-04-21
COBAS-FP TDM CONTROLS (K930269)Roche Diagnostic Systems, Inc.1993-02-25
DETECTABUSE(TM) (K925586)Biochemical Diagnostic, Inc.1992-12-28
DRUG OF ABUSE URINE CONTROL (K920477)Diagnostic Reagents, Inc.1992-03-18
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) (K914170)Bio-Rad1991-11-22
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL (K914806)Roche Diagnostic Systems, Inc.1991-11-19
TDM I LINEARITY TEST SET (K913309)Casco Standards1991-09-13
DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL (K913650)Duo Research, Inc.1991-09-06
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION (K911724)E.I. Dupont DE Nemours & Co., Inc.1991-05-22
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III (K911168)Analytical Control Systems, Inc.1991-05-01
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Every clearance here is in the API, with alerts when new ones post.