510(k) · Cleared
Recalled · Class III · 2020VITROS® Automation Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Oct 18, 2016 as substantially equivalent to K063144 (Ortho-Clinical Diagnostics, Inc., 2006) after a 239-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 18, 2016
- Review
- 239 days
- Class
- Class II
- Product code
- KLI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063144 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK063144 Vitros 5,1 FS Chemistry System with Engen Laboratory Automation SystemOrtho-Clinical Diagnostics, Inc. · 2006 · Recalled
- This deviceK160495 VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063144 | Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System | Ortho-Clinical Diagnostics, Inc. | 2006 | 35 |
| 0 (this device) | K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016 | — |
| +1 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| +2 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 KLI? 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? (2)
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 |
|---|---|---|---|
| * | K063144 | Vitros 5,1 FS Chemistry System with Engen Laboratory Automation SystemSummary page 4…is claimed Ortho claims that VITROS® Automation Solutions is substantially equivalent to the enGen™ Laboratory Automation System with VITROS® 5,1 FS Chemistry System K063144 Ortho-Clinical Diagnostics, Inc. Page 1 of 6 August 19, 2016 VITROS® Au… | 2006 |
| * | — | VITROS® Systems Named without a submission number | |
| † | K980283 | Vitros Chemistry Products CRBM Slides | 1998 |
| † | K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products… | 2005 |
| † | K964721 | Vitros Immunodiagnostics Products Total T4 Reagent Pack (Gem.1005) Total T4 Calibrators… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS… | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2020 | Class III | Z-1834-2020 | Under Investigation by firm | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K182063 (Ortho-Clinical Diagnostics, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KLI devicesKLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KLI
Too few KLI 510(k)s in any year since 2007 to give a median.
Recalls per year · KLI
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLI
3in 2021
MAUDE reports naming product code KLI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 1 | 7 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
VITROS® Automation Solutions is intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin. Carbamazepine measurements are used to monitor patient compliance and therapy, and…
Read the full statement (102 words)
VITROS® Automation Solutions is intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin.
Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total thyroxine (T4) measurements are used to aid in the differential diagnosis of thyroid disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160495 · printed Nov 3, 2026
Cite this page
510(k) Report. “K160495: VITROS® Automation Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K160495
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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