# K023876: Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 10, 2002 after 19 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K861386 (1986). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861386: Kodak Ektachem Clinical Chemistry Slides (MG), Eastman Kodak Company (1986) Summary page 3.
- K001885: Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1, Ortho-Clinical Diagnostics, Inc. (2000)

## Most influential descendants
- K072440: Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208) (2007), 1 descendant of its own
- K190520: VITROS XT Chemistry Products GLU-Ca Slides (2019), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0318-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
VITROS Chemistry Products Mg Slides For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine. VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Source page: https://510kreport.com/device/K023876
Methodology: https://510kreport.com/methodology