510(k) · Cleared
ClearedDade Behring N High Sensitivity CRP Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Oct 25, 1999 after a 187-day review. The FDA summary names no predicate by number. 32 later devices descend from it.
- Decided
- Oct 25, 1999
- Review
- 187 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 8 citing it directly.
- This deviceK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- Descendant · cites it directly · 23 of its ownK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
- Descendant · 2 generations on · 7 of its ownK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- Descendant · 3 generations on · 3 of its ownK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
- Descendant · 2 generations on · 2 of its ownK053603 C-Reactive Protein (Latex) High Sensitive Test System for Cobas…Roche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 2 of its ownK041799 Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K033908N High Sensitivity CRPDade Behring, Inc. · 2004 · cites it directly23descendants
- K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp. · 2004 · 2 generations on7descendants
- K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011 · 3 generations on3descendants
- K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp. · 2006 · 2 generations on2descendants
- K041799Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…Ortho-Clinical Diagnostics, Inc. · 2004 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| +1 | K033908 | N High Sensitivity CRP | Dade Behring, Inc. | 2004 | — |
| +2 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| +3 | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | — |
| +2 | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… | Roche Diagnostics Corp. | 2006 | — |
| +2 | K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 DCK? 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 DCK device
- #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (32)
See all 328 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033908 | N High Sensitivity CRP | 2004 | 23 |
| K030545 | CRP-Latex (II)X2 Seiken Assay Kit | 2003 | 2 |
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP | 2006 | 1 |
| K032663 | Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls… | 2003 | 0 |
| K030899 | C-Reactive Protein (CRP) | 2003 | 0 |
| K023269 | Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls | 2002 | 0 |
| K011855 | Wampole HS-CRP Elisa | 2002 | 0 |
| K012337 | Bayer Advia Ims System; C-Reactive Protein System | 2001 | 0 |
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?
- Of its descendants, K033908 (Dade Behring, Inc., 2004) has gone furthest, with 23 descendants of its own.
How does its category compare?
All DCK devicesDCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DCK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DCK
Too few DCK 510(k)s in any year since 2007 to give a median.
Recalls per year · DCK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCK
1in 2021
MAUDE reports naming product code DCK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dade Behring N High Sensitivity CRP assay is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum as well as heparin- and EDTA-plasma by means of particle-enhanced immunonephelometry using Dade Behring Nephelometer Systems. 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/K991385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991385: Dade Behring N High Sensitivity CRP Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991385
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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