Atlas FDA

ONLINE DAT Benzodiazepines II

FDA 510(k) clearance K221765 · decided 2022-12-23

Clearance details

K-number
K221765
Device name
ONLINE DAT Benzodiazepines II
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2022-06-17
Decision date
2022-12-23
Days to decision
189 days
Clearance type
Traditional
Product code
JXM
Device class
2
Regulation number
862.3170
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Alinity c Benzodiazepines Reagent Kit (K243498)Microgenics Corporation2024-12-11
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01