510(k) · Cleared
Recalled · 2009K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamiya Biomedical Co. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Feb 4, 2003 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- DCK
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK023828 K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D…Kamiya Biomedical Co. · 2003
- Descendant · cites it directly · 0 of its ownK242170 K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC · 2025
- Descendant · cites it directly · 0 of its ownK061138 Abx Pentra 400 : CRPHoriba Abx · 2006
- Descendant · cites it directly · 0 of its ownK050713 Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator…Good Biotech Corp. · 2005
Most influential descendants
Showing 3 of 3 · See all- K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC · 2025 · cites it directly0descendants
- K061138Abx Pentra 400 : CRPHoriba Abx · 2006 · cites it directly0descendants
- K050713Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set, Catalog Number…Good Biotech Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP… | Kamiya Biomedical Co. | 2003 | — |
| +1 | K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | 2025 | — |
| +1 | K061138 | Abx Pentra 400 : CRP | Horiba Abx | 2006 | — |
| +1 | K050713 | Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set… | Good Biotech Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2009 | Not classified | Z-0973-2010 | Other | The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K242170 (Kamiya Biomedical Company, LLC, 2025) has gone furthest, with 0 descendants of its own.
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 K-ASSAY @ CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.
The K-ASSAY CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY CRP (3) Assay.
The K-ASSAY CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY @ CRP (3) Assay.
The K-ASSAY CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY @ CRP (3) Assay.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023828: K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023828
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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