# K030626: Vitros Chemistry Products CRP Slide and Calibrator Kit 7

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Mar 18, 2003 after 19 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953197 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953197: Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP), Johnson & Johnson Clinical Diagnostics, Inc. (1995) Summary page 3.

## Most influential descendants
- K152433: VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (2015), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0309-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Nov 22, 2004 · Not classified · Z-0387-05: Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
- Jul 28, 2004 · Not classified · Z-1473-04: The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

## Indications for use
Vitros Chemistry Products CRP Slides For in vitro diagnostic use only. Vitros Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. Vitros Chemistry Products Calibrator Kit 7 For in vitro diagnostic use only. Vitros Calibrator Kit 7 is intended for use in the calibration of the Yitros Chemistry Systems for the quantitative measurement of CRP.

Source page: https://510kreport.com/device/K030626
Methodology: https://510kreport.com/methodology