510(k) · Cleared
ClearedAdvia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Diagnostics · DCN System, Test, C-Reactive Protein
Cleared on Apr 1, 2008 as substantially equivalent to K992662 (Bayer Corp., 2000) and 1 other predicate after a 194-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 1, 2008
- Review
- 194 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992662 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992662 8 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 2000 · Recalled
- This deviceK072658 Advia Chemistry C-Reactive Protein_2, (CRP_2) and CalibratorsSiemens Medical Solutions Diagnostics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992662 | 8 Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 2000 | 1 |
| 0 (this device) | K072658 | Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators | Siemens Medical Solutions Diagnostics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 DCN? 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 DCN device
- #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K992662 | 8 Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 1…vice Device Name ADVIA ® Chemistry Systems C-Reactive Protein Common name C-Reactive Protein Immunological Test System 510(k) Number k992662 Manufacturer Siemens Healthcare Diagnostics (formerly Siemens Medical Solutions Diagnostics… | 2000 |
| * | K022682 | Randox C-Reactive Protein CalibratorSummary page 2…Predicate Device Device Name ADVIA Chemistry wrCRP Calibrators Common name C-Reactive Protein 510(k) Number K022682 (Randox Labs, Ltd) Manufacturer Siemens Medical Solutions Diagnostics (formerly Bayer Health… | 2002 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All DCN devicesDCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DCN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DCN
234in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCN
7in 2025
MAUDE reports naming product code DCN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 3 | 111 | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 234 | 0 | 2 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 1 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ADVIA CHEMISTRY C-Reactive Protein_2 assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin) on the ADVIA Chemistry systems. Such measurements are used in the evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Increases in CRP values are non-specific for many disease processes and should not be interpreted without a complete clinical evaluation.
The ADVIA Chemistry C-Reactive Protein_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the C-Reactive Protein_2 (CRP_2) method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072658: Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072658
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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