510(k) · Cleared
Recalled · Class II · 2020C-Reactive Protein (Latex)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DCN System, Test, C-Reactive Protein
Cleared on Mar 18, 2009 as substantially equivalent to K032336 (Roche Diagnostics Corp., 2003) after a 117-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2009
- Review
- 117 days
- Class
- Class II
- Product code
- DCN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895880 (1989). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 3 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 2 generations backK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- 1 generation backK032336 Tina-Quant CRP (Latex)Roche Diagnostics Corp. · 2003
- This deviceK083444 C-Reactive Protein (Latex)Roche Diagnostics Corp. · 2009
- Descendant · cites it directly · 0 of its ownK192072 Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo) · 2020
- Descendant · cites it directly · 0 of its ownK161982 C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group · 2017 · Recalled
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 |
|---|---|---|---|---|---|
| −4 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −3 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −2 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| −1 | K032336 | Tina-Quant CRP (Latex) | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K083444 | C-Reactive Protein (Latex) | Roche Diagnostics Corp. | 2009 | — |
| +1 | K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | 2020 | — |
| +1 | K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K032336 | Tina-Quant CRP (Latex)Summary page 1…vide notification of modifications to our Tina- Quant C-Reactive Protein Gen 3 assay. This assay was most recently cleared for use in K032336 on the Roche/Hitachi Clinical Chemistry analyzers. Since the K032336 filing, modifications t… | 2003 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Nov 6, 2020 | Class II | Z-0634-2021 | Process control | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K192072 (Roche Diagnostics Operations (Rdo), 2020) has gone furthest, with 0 descendants of its own.
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. 2009, 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?
Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083444: C-Reactive Protein (Latex).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083444
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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