Atlas FDA

VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM

FDA 510(k) clearance K063144 · decided 2006-11-13

Clearance details

K-number
K063144
Device name
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2006-10-16
Decision date
2006-11-13
Days to decision
28 days
Clearance type
Special
Product code
JJE
Device class
1
Regulation number
862.2160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 recall (Z-2143-2016)Ortho-Clinical Diagnostics2016-07-08
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 1075 recall (Z-1073-2016)Ortho-Clinical Diagnostics2016-03-08
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10 recall (Z-1075-2016)Ortho-Clinical Diagnostics2016-03-08
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 1075 recall (Z-0642-2016)Ortho-Clinical Diagnostics2016-01-13
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10 recall (Z-0643-2016)Ortho-Clinical Diagnostics2016-01-13
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identif recall (Z-0231-2016)Ortho-Clinical Diagnostics2015-11-05
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all recall (Z-1724-2015)Ortho-Clinical Diagnostics2015-06-08
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automate recall (Z-1729-2015)Ortho-Clinical Diagnostics2015-06-08
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, G recall (Z-1521-2015)Ortho-Clinical Diagnostics2015-04-25
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems ( recall (Z-1004-2015)Ortho-Clinical Diagnostics2015-01-20
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagno recall (Z-0967-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, recall (Z-0968-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. recall (Z-0969-2015)Ortho-Clinical Diagnostics2015-01-14
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 680 recall (Z-0077-2015)Ortho-Clinical Diagnostics2014-10-16
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chem recall (Z-2140-2014)Ortho-Clinical Diagnostics2014-08-01
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For recall (Z-1741-2014)Ortho-Clinical Diagnostics2014-06-10
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Number recall (Z-1736-2014)Ortho-Clinical Diagnostics2014-06-09
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative recall (Z-1738-2014)Ortho-Clinical Diagnostics2014-06-09
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument M recall (Z-1677-2014)Ortho-Clinical Diagnostics2014-06-02
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Re recall (Z-1106-2013)Ortho-Clinical Diagnostics2013-04-13
VITROS® 5,1 FS System, Product Codes: 6801375 & 68 recall (Z-1471-2012)Ortho-Clinical Diagnostics2012-04-26
VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 &amp recall (Z-1472-2012)Ortho-Clinical Diagnostics2012-04-26
enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Cen recall (Z-0914-2012)Ortho-Clinical Diagnostics2012-01-26
VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VIT recall (Z-1167-2007)Ortho-Clinical Diagnostics2007-08-16

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19