# K161140: VITROS Chemistry Products Calibrator Kit 3

- Pathway: 510(k) (Abbreviated)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 20, 2016 after 28 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001679 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001679: Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3, Ortho-Clinical Diagnostics, Inc. (2000) Summary page 4.

## Indications for use
For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, and LIPA.

Source page: https://510kreport.com/device/K161140
Methodology: https://510kreport.com/methodology