# K030545: CRP-Latex (II)X2 Seiken Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken Co., Ltd.
- Decided: Jun 2, 2003 after 102 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- 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 K991385 (1999). 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)
- K991385: Dade Behring N High Sensitivity CRP Assay, Dade Behring, Inc. (1999) Summary page 1.

## Most influential descendants
- K050836: CRP Diagnostic Assay (2005), 1 descendant of its own
- K192118: CRP Vario (2019), 0 descendants of its own

## Recalls of this device
- Jul 21, 2009 · Class III · Z-2631-2017: Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.

## Indications for use
The CRP-Latex (II)X2 SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

Source page: https://510kreport.com/device/K030545
Methodology: https://510kreport.com/methodology