510(k) · Cleared
ClearedPiccolo C-Reactive Protein (CRP) Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · DCN System, Test, C-Reactive Protein
Cleared on Jan 15, 2010 as substantially equivalent to K070626 (Beckman Coulter, Inc., 2007) after a 277-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jan 15, 2010
- Review
- 277 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991385 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- 2 generations backK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
- 1 generation backK070626 Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH)…Beckman Coulter, Inc. · 2007
- This deviceK091052 Piccolo C-Reactive Protein (CRP) Test SystemAbaxis, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| −2 | K033908 | N High Sensitivity CRP | Dade Behring, Inc. | 2004 | — |
| −1 | K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent | Beckman Coulter, Inc. | 2007 | — |
| 0 (this device) | K091052 | Piccolo C-Reactive Protein (CRP) Test System | Abaxis, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentSummary page 1…_______________________ ~~Number Determination High Sensitivity Beckman Coulter, K070626 05/04/07 C-Reactive Protein Ind. (Brea, CA) Synchron LX20 4.… | 2007 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
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. 2010, 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?
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction With other laboratory and clinical finidings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091052: Piccolo C-Reactive Protein (CRP) Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091052
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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