510(k) · Cleared
ClearedRoche-Creactive 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 6, 2008 as substantially equivalent to K981897 (Roche Diagnostic Systems, Inc., 1998) after a 106-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- Mar 6, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895880 (1989). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 1 generation backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- This deviceK073277 Roche-Creactive Protein (Latex)Roche Diagnostics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK171498 MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK113809 Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein…Hitachi Chemical Diagnostics, Inc. · 2012
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 |
|---|---|---|---|---|---|
| −2 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −1 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K073277 | Roche-Creactive Protein (Latex) | Roche Diagnostics Corp. | 2008 | — |
| +1 | K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | 2018 | — |
| +1 | K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP) | Hitachi Chemical Diagnostics, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas…Summary page 1…fication Purpose to provide notification of modifications to our C-Reactive Protein (Latex) assay. This assay was originally cleared for use in K981897 on the COBAS Integra 700 (analyzer cleared in K951595). Submission history for additional appli… | 1998 |
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)
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 19 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K171498 (Meso Scale Diagnostics, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K981897.
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?
In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma on COBAS iNTEGRA systems.
In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073277: Roche-Creactive Protein (Latex).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073277
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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