510(k) · Cleared
Recalled · 2008Immage Immunochemistry System C-Reactive Protein (CRP) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Jun 12, 1998 as substantially equivalent to K962523 (Behring Diagnostics, Inc., 1996) after a 35-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 12, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- DCK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860894 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- 1 generation backK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
- This deviceK981638 Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK050836 CRP Diagnostic AssaySentinel Ch. Srl · 2005
- Descendant · 2 generations on · 0 of its ownK192118 CRP VarioSENTINEL CH. SpA · 2019
- Descendant · cites it directly · 0 of its ownK022690 Paros CRPHoriba, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK990704 Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc. · 1999
Most influential descendants
Showing 4 of 4 · See all- K050836CRP Diagnostic AssaySentinel Ch. Srl · 2005 · cites it directly1descendant
- K192118CRP VarioSENTINEL CH. SpA · 2019 · 2 generations on0descendants
- K022690Paros CRPHoriba, Ltd. · 2002 · cites it directly0descendants
- K990704Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| −1 | K962523 | N Latex CRP Mono Reagent | Behring Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) Reagent | Beckman Coulter, Inc. | 1998 | — |
| +1 | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
| +2 | K192118 | CRP Vario | SENTINEL CH. SpA | 2019 | — |
| +1 | K022690 | Paros CRP | Horiba, Ltd. | 2002 | — |
| +1 | K990704 | Array 360 System C-Reactive Protein (CRP Mpe) Reagent | Beckman Coulter, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K962523 | N Latex CRP Mono ReagentSummary page 1…tem C-Reactive Protein (CRP) Reagent 3.2 Classification Name C-Reactive Protein immunological test system (21 CFR § 866.5270) Behring N Latex CRP Behring Diagnostics* K962523 IMMAGE System C-Reactive Protein (CRP) Reagent * Behring Diagnostics (Westwood, MA) Description: The IMMAGE Immunochemistry S… | 1996 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Jan 10, 2008 | Not classified | Z-0921-2010 | Other | IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050836 (Sentinel Ch. Srl, 2005) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K962523.
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 IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.
Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.
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/K981638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981638: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981638
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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