# K063591: Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products Calibrator Kit 1,Model#1882208

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 15, 2006 after 14 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001310 (2000). 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)
- K001310: Vitros Chemistry  Products Crea Slide, Virtros Chemistry Products Calibrator Kit 1, Ortho-Clinical Diagnostics, Inc. (2000) Summary page 1.

## 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
- Jul 11, 2018 · Class III · Z-3193-2018: The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the m
- Jun 12, 2013 · Class II · Z-0308-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
For in vitro diagnostic use only. VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate 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/K063591
Methodology: https://510kreport.com/methodology