# K063144: Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 13, 2006 after 28 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VITROS dHDL assay performed on the VITROS 5,1 FS Chemistry System: named in the summary without a submission number

## Most influential descendants
- K160495: VITROS® Automation Solutions (2016), 2 descendants of its own
- K182063: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (2018), 1 descendant of its own
- K190326: VITROS XT Chemistry Products UREA-CREA Slides (2019), 0 descendants of its own

## Recalls of this device
- Jul 8, 2019 · Class II · Z-2181-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2184-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2183-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2182-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Oct 19, 2018 · Class II · Z-0651-2019: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
- Oct 19, 2018 · Class II · Z-0653-2019: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
- Apr 26, 2017 · Class II · Z-0254-2018: A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto th
- Mar 8, 2017 · Class II · Z-2077-2017: Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs inv
- Sep 7, 2016 · Class II · Z-0300-2017: Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay re
- May 16, 2016 · Class III · Z-2143-2016: If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Bo
- Mar 17, 2016 · Class II · Z-1569-2016: The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the suppo
- Dec 21, 2015 · Class II · Z-1075-2016: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions f
- Dec 21, 2015 · Class II · Z-1073-2016: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions f
- Nov 3, 2015 · Class II · Z-0643-2016: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermitten
- Nov 3, 2015 · Class II · Z-0642-2016: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermitten
- Sep 10, 2015 · Class II · Z-0231-2016: Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed
- May 6, 2015 · Class II · Z-1724-2015: Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Ex
- Apr 6, 2015 · Class II · Z-1729-2015: Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample c
- Mar 10, 2015 · Class II · Z-1521-2015: Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previo
- Nov 19, 2014 · Class II · Z-0967-2015: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
- Nov 19, 2014 · Class II · Z-0969-2015: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
- Nov 19, 2014 · Class II · Z-0968-2015: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
- Sep 29, 2014 · Class III · Z-1004-2015: Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
- Sep 8, 2014 · Class II · Z-0077-2015: Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when usin
- Jul 7, 2014 · Class II · Z-2140-2014: Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics w
- Apr 17, 2014 · Class II · Z-1741-2014: Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
- Apr 10, 2014 · Class II · Z-1736-2014: Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry S
- Apr 10, 2014 · Class II · Z-1738-2014: Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur,
- Mar 20, 2014 · Class II · Z-1677-2014: Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample 
- Jun 6, 2013 · Class II · Z-1948-2013: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
- Feb 7, 2013 · Class II · Z-1106-2013: Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide
- Mar 15, 2012 · Not classified · Z-1471-2012: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Mar 15, 2012 · Not classified · Z-1472-2012: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Apr 28, 2011 · Not classified · Z-0914-2012: Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 481
- May 17, 2007 · Not classified · Z-1167-2007: Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VI

## Indications for use
The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are used for the quantitative measurement of HDL cholesterol in serum or plasma.

Source page: https://510kreport.com/device/K063144
Methodology: https://510kreport.com/methodology