510(k) · Cleared
Recalled · Class II · 2025Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator Kit 19, FS Calibrator 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · JIT Calibrator, Secondary
Cleared on Aug 7, 2003 as substantially equivalent to K946090 (Clinical Diagnostic Systems, Inc., 1995) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 29 times.
- Decided
- Aug 7, 2003
- Review
- 45 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 29
- Predicates
- 3
Its longest line of descent runs back 1 generation to K946090 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946090 Kodak Ektacchem 950IRC AnalyzerClinical Diagnostic Systems, Inc. · 1995 · Recalled
- This deviceK031924 Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL…Ortho-Clinical Diagnostics · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946090 | Kodak Ektacchem 950IRC Analyzer | Clinical Diagnostic Systems, Inc. | 1995 | 1 |
| 0 (this device) | K031924 | Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack… | Ortho-Clinical Diagnostics | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K946090 | Kodak Ektacchem 950IRC AnalyzerSummary page 2…cate devices 1. VITROS Chemistry Products 5,l 1. VITROS 950 Chemistry System FDA FS Chemistry System 5 1O(k) Number K946090 2. Bayer ADVIA 1650 Chemistry System… | 1995 |
| * | K990346 | Bayer Advia 1650 Chemistry SystemSummary page 2…946090 2. Bayer ADVIA 1650 Chemistry System FDA 5 1O(k) Number K990346 2. VITROS Chemistry Products 3. Bayer Direct HDL Cholesterol I1 dHDL assay… | 1999 |
| * | K982341 | Direct HDL-Cholestrol LiquidSummary page 2…r K990346 2. VITROS Chemistry Products 3. Bayer Direct HDL Cholesterol I1 dHDL assay FDA Docket Number K982341 1.6 Intended Use Statement(s) The VITROS 5,l FS Chemistry System is a random access, fully automated c… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2025 | Class II | Z-2040-2025 | Software design | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during… |
| Jan 26, 2024 | Class II | Z-1225-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported. |
| Jan 26, 2024 | Class II | Z-1230-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not… |
| Oct 10, 2023 | Class II | Z-0544-2024 | Under Investigation by firm | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or… |
| Aug 9, 2023 | Class II | Z-0008-2024 | Under Investigation by firm | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification… |
| Dec 21, 2015 | Class II | Z-1075-2016 | Error in labeling | 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 following U90-382 or 6LU condition… |
| Dec 21, 2015 | Class II | Z-1073-2016 | Error in labeling | 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 following U90-382 or 6LU condition… |
| Nov 3, 2015 | Class II | Z-0643-2016 | Software design | 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 intermittent issue occurs, the VITROS Systems… |
| Nov 3, 2015 | Class II | Z-0642-2016 | Software design | 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 intermittent issue occurs, the VITROS Systems… |
| Sep 10, 2015 | Class II | Z-0231-2016 | Software design | 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 to the default values obtained from… |
| Jun 30, 2015 | Class II | Z-2544-2015 | Software design | Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified) parameters, ALL default settings are restored in the VITROS… |
| Mar 10, 2015 | Class II | Z-1521-2015 | Software in the Use Environment | 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 previously, an indication would be a series… |
| Nov 19, 2014 | Class II | Z-0967-2015 | Software design | 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 design | 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 design | 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 | Software Manufacturing/Software Deployment | 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 | Software design | 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 using calibrator barcode labels supplied… |
| Jul 7, 2014 | Class II | Z-2140-2014 | Software in the Use Environment | 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 were associated with a sample… |
| Apr 10, 2014 | Class II | Z-1736-2014 | Software design | 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 System. MW codes may be associated with… |
| Apr 10, 2014 | Class II | Z-1734-2014 | Software design | 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 System. MW codes may be associated with… |
| Jun 6, 2013 | Class II | Z-1948-2013 | Nonconforming Material/Component | 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. |
| May 6, 2013 | Class II | Z-1647-2013 | Device Design | There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt. |
| May 6, 2013 | Class II | Z-1648-2013 | Device Design | There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt. |
| Feb 7, 2013 | Class II | Z-1106-2013 | Nonconforming Material/Component | 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 assembly. During an internal… |
| Feb 7, 2013 | Class II | Z-1107-2013 | Nonconforming Material/Component | 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 assembly. During an internal… |
| May 21, 2012 | Class II | Z-2067-2012 | Software design | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment. |
| May 21, 2012 | Class II | Z-2066-2012 | Software design | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment. |
| Mar 15, 2012 | Not classified | Z-1469-2012 | Nonconforming Material/Component | Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. |
| May 17, 2007 | Not classified | Z-1167-2007 | Other | 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 VITROS Chemistry Products THC Reagent. A… |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 3 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K946090.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The VITROS 5,1 FS Chemistry 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.) For in vitro diagnostic use only. The VITROS dHDL Reagent Pack…
Read the full statement (165 words)
The VITROS 5,1 FS Chemistry 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.)
For in vitro diagnostic use only. The VITROS dHDL Reagent Pack quantitatively measures HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate dHDL.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is a saline solution used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Calibrator Kit 19 to calibrate dHDL.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031924: Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator Kit 19, FS Calibrator 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031924
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026