# K030546: CRP (II) Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken Co., Ltd.
- Decided: Jun 2, 2003 after 102 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) N High Sensitivity CRP Assay: named in the summary without a submission number

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

## Indications for use
The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex 0 x 2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples.

Source page: https://510kreport.com/device/K030546
Methodology: https://510kreport.com/methodology