510(k) · Cleared
ClearedCRP HS Test System
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 May 10, 2001 as substantially equivalent to K981897 (Roche Diagnostic Systems, Inc., 1998) after a 190-day review. Its family tree reaches back 2 generations to 1989. 12 later devices descend from it.
- Decided
- May 10, 2001
- Review
- 190 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. 12 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 deviceK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 7 of its ownK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
- Descendant · cites it directly · 3 of its ownK032336 Tina-Quant CRP (Latex)Roche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK083444 C-Reactive Protein (Latex)Roche Diagnostics Corp. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK053603 C-Reactive Protein (Latex) High Sensitive Test System for Cobas…Roche Diagnostics Corp. · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp. · 2004 · cites it directly7descendants
- K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011 · 2 generations on3descendants
- K032336Tina-Quant CRP (Latex)Roche Diagnostics Corp. · 2003 · cites it directly3descendants
- K083444C-Reactive Protein (Latex)Roche Diagnostics Corp. · 2009 · 2 generations on2descendants
- K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp. · 2006 · 2 generations on2descendants
View 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) | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| +1 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| +2 | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | — |
| +1 | K032336 | Tina-Quant CRP (Latex) | Roche Diagnostics Corp. | 2003 | — |
| +2 | K083444 | C-Reactive Protein (Latex) | Roche Diagnostics Corp. | 2009 | 1 |
| +2 | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… | Roche Diagnostics Corp. | 2006 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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…and infection. The CRP US test is equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Integra C-Reactive Protein test (K981897). 510(k) Summary ! 510(k) Summary - CRP US on Roche / Hitachi Family of Clinical Analyzers, continued Substanti… | 1998 |
What descends from it? (12)
See all 122 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 12 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K042485 (Roche Diagnostics Corp., 2004) has gone furthest, with 7 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.
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?
For the quantitative determination of C-reactive protein in human serum and plasma. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K003400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003400: CRP HS 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/K003400
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026