# K152433: VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

- Pathway: 510(k) (Special)
- Applicant: Ortho Clinical Diagnostics
- Decided: Sep 24, 2015 after 28 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: 2 generations back to K953197 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030626: Vitros Chemistry Products CRP Slide and Calibrator Kit 7, Ortho-Clinical Diagnostics, Inc. (2003) Summary page 4.

## Recalls of this device
- Apr 14, 2025 · Class II · Z-1876-2025: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
- Oct 11, 2024 · Class II · Z-0535-2025: May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg
- Oct 26, 2016 · Class III · Z-0864-2017: CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the end

## 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 using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. C-reactive protein is synthesized by the liver and is one of the acute phase proteins. In the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections. VITROS Chemistry Products Calibrator Kit 7: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 7 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 CRP.

Source page: https://510kreport.com/device/K152433
Methodology: https://510kreport.com/methodology