510(k) · Cleared
Recalled · Class III · 2009CRP-Latex (II)X2 Seiken Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denka Seiken Co., Ltd. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Jun 2, 2003 as substantially equivalent to K991385 (Dade Behring, Inc., 1999) after a 102-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 2, 2003
- Review
- 102 days
- Class
- Class II
- Product code
- DCK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991385 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- This deviceK030545 CRP-Latex (II)X2 Seiken Assay KitDenka Seiken Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK050836 CRP Diagnostic AssaySentinel Ch. Srl · 2005
- Descendant · 2 generations on · 0 of its ownK192118 CRP VarioSENTINEL CH. SpA · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K030545 | CRP-Latex (II)X2 Seiken Assay Kit | Denka Seiken Co., Ltd. | 2003 | — |
| +1 | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
| +2 | K192118 | CRP Vario | SENTINEL CH. SpA | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DCK device
- #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991385 | Dade Behring N High Sensitivity CRP AssaySummary page 1…Class: II (3) Legally marketed predicate device: N High Sensitivity CRP Assay [Dade Behring Inc, l(K991385). (4) Subject device description: The CRP-Latex (WX2 S E W N Assay Kit is a latex in vitro diagnostic immu… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050836 | CRP Diagnostic Assay | 2005 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2009 | Class III | Z-2631-2017 | Error in labeling | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DCK devicesDCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DCK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DCK
Too few DCK 510(k)s in any year since 2007 to give a median.
Recalls per year · DCK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCK
1in 2021
MAUDE reports naming product code DCK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030545: CRP-Latex (II)X2 Seiken Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030545
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026