# K953197: Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Jul 31, 1995 after 21 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041799: Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS (2004), 2 descendants of its own
- K030626: Vitros Chemistry Products CRP Slide and Calibrator Kit 7 (2003), 1 descendant of its own
- K152433: VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (2015), 0 descendants of its own
- K141689: FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (2015), 0 descendants of its own
- K042838: Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance Verifiers I & II (2004), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K953197
Methodology: https://510kreport.com/methodology