# K160495: VITROS® Automation Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 18, 2016 after 239 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063144 (2006). 1 ancestor in all.
2 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)
- K063144: Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System, Ortho-Clinical Diagnostics, Inc. (2006) Summary page 4.
- (no number) VITROS® Systems: named in the summary without a submission number

## Most influential descendants
- 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
- Mar 10, 2020 · Class III · Z-1834-2020: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

## Indications for use
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.

Source page: https://510kreport.com/device/K160495
Methodology: https://510kreport.com/methodology