510(k) · Cleared
ClearedDimension Cardiophase High Sensitivity C-Reactive Protein Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIS Calibrator, Primary
Cleared on Dec 23, 2005 as substantially equivalent to K964527 (Behring Diagnostics, Inc., 1997) after a 49-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 23, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964527 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964527 N Rheumatology Standard SLBehring Diagnostics, Inc. · 1997
- This deviceK053104 Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorDade Behring, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964527 | N Rheumatology Standard SL | Behring Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein Calibrator | Dade Behring, Inc. | 2005 | — |
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 JIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K964527 | N Rheumatology Standard SLSummary page 2…human C-reactive protein. I. Substantial Equivalence Information: 1. Predicate device name(s): N Rheumatology Standard SL on the BN Systems. 2. Predicate K number(s): K964527 3. Comparison with predicate: Similarities Dimension® CardioPhas… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K964527.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardkoPlhase high sensitivity C-reactive protein (Cat. No. RF434) method for the Dimension® clinical chemistry system with the heterogeneous immunoasay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053104: Dimension Cardiophase High Sensitivity C-Reactive Protein Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053104
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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