Atlas FDA

JXM

90 FDA 510(k) clearances · Product code

59 daysmedian time to decision
184 days90th percentile
90clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Benzodiazepine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3170
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 1 · 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Alinity c Benzodiazepines Reagent Kit (K243498)Microgenics Corporation2024-12-11
ONLINE DAT Benzodiazepines II (K221765)Roche Diagnostics2022-12-23
CEDIA Benzodiazepine Assay (K190968)Microgenics Corporation2019-12-09
DRI Benzodiazepine Assay (K173963)Microgenics Corporation2018-02-21
Psychemedics Microplate EIA for Benzodiazepines in Hair (K163590)Psychemedics Corporation2017-09-15
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (K163704)Healgen Scientific,, LLC2017-08-02
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K153597)Healgen Scientific,, LLC2016-05-23
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K151771)Immunalysis Corporation2016-01-05
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K151642)Healgen Scientific,, LLC2015-08-13
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K150356)Healgen Scientific,, LLC2015-05-13
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS (K123080)Chemtron Biotech, Inc.2012-11-29
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD (K111322)Chemtron Biotech, Inc.2011-09-14
RANDOX BENZODIAZEPINE ASSAY (K092274)Randox Laboratories, Ltd.2010-10-15
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062285)Ortho-Clinical Diagnostics, Inc.2006-12-22
ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 (K060354)Acro Biotech, LLC2006-07-28
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT (K051307)Beckman Coulter, Inc.2005-06-13
RANDOX BENZODIAZEPINE CLASS ASSAY (K050179)Randox Laboratories, Ltd.2005-05-17
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT (K043556)Beckman Coulter, Inc.2005-03-28
ONLINE DAT BENZODIAZEPINES PLUS (K043327)Roche Diagnostics Corp.2005-02-07
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X (K043167)Phamatech, Inc.2004-12-29
BENZODIAZEPINE ENZYME IMMUNOASSAY (K032365)Lin-Zhi International, Inc.2003-09-05
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT (K023048)Beckman Coulter, Inc.2002-11-07
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (K013882)OraSure Technologies, Inc.2002-04-17
BENZODIAZEPINES (K013143)Abbott Laboratories2002-03-13
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE (K012300)ACON Laboratories, Inc.2001-09-17
LIVESURE BENZODIAZEPINES SCREEN TESTS (K012131)Pan Probe Biotech, Inc.2001-07-20
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST (K003881)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) (K003879)Alfa Scientific Designs, Inc.2001-05-29
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 (K011306)Syva Co., Dade Behring, Inc.2001-05-16
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST (K002342)Branan Medical Corporation2000-11-27
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A (K000458)Dade Behring, Inc.2000-04-17
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST (K000449)Drug Detection Devices, Ltd.2000-04-07
RAPIDONE- BENZODIAZEPINE TEST (K992720)American Bio Medica Corp.2000-04-03
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (K993985)Syva Co.2000-01-27
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) (K991443)Roche Diagnostics Corp.1999-06-22
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO (K991079)Princeton BioMeditech Corp.1999-04-15
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (K983702)Roche Diagnostic Systems, Inc.1999-02-11
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES (K983174)Roche Diagnostic Systems, Inc.1998-11-18
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U (K982831)OraSure Technologies, Inc.1998-11-12
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 (K981687)Phamatech1998-06-03
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST (K980776)Tcpi, Inc.1998-04-29
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST (K973269)Drial Consultants, Inc.1998-02-25
QUIKPAC II ONE STEP BENZODIAZEPINE TEST (K973326)Drial Consultants, Inc.1998-02-24
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B (K974181)Princeton BioMeditech Corp.1997-12-11
CEDIA DAU BENZODIAZEPINE ASSAY (K962734)Boehringer Mannheim Corp.1996-12-10
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY (K962672)Princeton BioMeditech Corp.1996-08-30
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP (K961325)Princeton BioMeditech Corp.1996-06-12
BENZODIAZEPINE SERUM TOX EIA TEST (K960708)Diagnostic Reagents, Inc.1996-05-20
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION) (K954626)Microgenics Corp.1995-11-27
VISUALINE II BENZODIAZEPINES (K953105)Sun Biomedical Laboratories, Inc.1995-10-05
CEDIA DAU BENZODIAZEPINE ASSAY (K951710)Microgenics Corp.1995-06-20
AXSYM BENZODIAZEPINES (K951286)Abbott Laboratories1995-05-16
AXSYM CANNABINOIDS (K951288)Abbott Laboratories1995-05-16
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (K950427)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
MICROLINE SCREEN FOR BENZODIAZEPINE (K945829)Drug Screening Systems, Inc.1995-01-25
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS (K944076)Beckman Instruments, Inc.1994-11-21
CEDIA DAU BENZODIAZEPINE ASSAY (K942795)Microgenics Corp.1994-08-01
CEDIA DAU BENZODIAZEPINE ASSAY (K940159)Microgenics Corp.1994-05-27
STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA (K934869)Solarcare Technologies Corp,Inc.1993-11-22
BENZODIAZEPINE ENZYME IMMUNOASSAY (K930529)Diagnostic Reagents, Inc.1993-08-05
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY (K931536)Syva Co.1993-05-11
EMIT(R) II BENZODIAZEPINE ASSAY (K926067)Syva Co.1993-01-12
EMIT D.A.U BENZODIAZEPINE ASSAY (K915501)Syva Co.1992-02-18
IL TEST(TM) BENZODIAZEPINE (K914815)Instrumentation Laboratory CO1992-01-27
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES (K914509)Roche Diagnostic Systems, Inc.1991-11-01
ABUSCREEN ONTRAK FOR BENZODIAZEPINE (K910590)Roche Diagnostic Systems, Inc.1991-04-05
EMIT II BENZODIAZEPINE ASSAY (K910376)Syva Co.1991-02-22
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (K896780)Immunotech Corp.1990-03-23
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC (K896744)Bio-Rad1990-02-23
ADX TM BENZODIAZEPINES (K890691)Abbott Laboratories1989-08-25
ABUSCREEN FP BENZODIAZEPHINE REAGENT (K891697)Roche Diagnostic Systems, Inc.1989-03-31
DOUBLE ANTIBODY SERUM BENZODIAZEPINES (K890001)Diagnostic Products Corp.1989-01-24
TDX BENZODIAZEPINES SERUM (K883730)Abbott Laboratories1988-11-29
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5 (K883459)Diagnostic Products Corp.1988-09-09
REVISIED LABELING FOR ADX BENZODIAZEPINES (K880014)Abbott Laboratories1988-02-11
REVISED LABELING FOR TDX BENZODIAZEPINES (K874489)Abbott Laboratories1987-11-23
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS (K874376)Syva Co.1987-11-23
REVISED LABELING FOR BENZODIAZEPINE TEST KIT (K874265)Roche Diagnostic Systems, Inc.1987-11-13
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD (K873538)E.I. Dupont DE Nemours & Co., Inc.1987-10-02
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES (K870994)Roche Diagnostic Systems, Inc.1987-03-24
BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (K863877)General Diagnostics1987-03-12
TDX BENZODIAZEPINES (K862250)Abbott Laboratories1986-07-11
EMIT 700 BENZODIAZEPINE ASSAY (K851568)Syva Co.1985-05-10
EMIT D.A.U. BENZODIAZEPINE ASSAY (K842815)Syva Co.1984-09-26
ACA BENZODIAZEPINES SCREEN TEST PK (K842387)E.I. Dupont DE Nemours & Co., Inc.1984-08-15
EMIT ST SERUM BENZODIAZEPINE ASSAY (K840236)Syva Co.1984-03-19
MODIF. OF EMIT URINE BENZODIAZEPINE (K833578)Syva Co.1984-01-26
EMIT-ST SERUM BENZODIAZEPINE ASSAY (K810463)Syva Co.1981-03-06
EMIT-STM BENZODIAZEPINE ASSAY (K802616)Syva Co.1980-10-31
EMIT-TOX SERUM BENZODIAZEPINE ASSAY (K790736)Syva Co.1979-04-26

Track JXM automatically

Every clearance here is in the API, with alerts when new ones post.