510(k) · Cleared
ClearedArray 360 System C-Reactive Protein (CRP Mpe) 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 May 3, 1999 as substantially equivalent to K981638 (Beckman Coulter, Inc., 1998) after a 60-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- May 3, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K860894 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- 2 generations backK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
- 1 generation backK981638 Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc. · 1998 · Recalled
- This deviceK990704 Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| −2 | K962523 | N Latex CRP Mono Reagent | Behring Diagnostics, Inc. | 1996 | — |
| −1 | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) Reagent | Beckman Coulter, Inc. | 1998 | 1 |
| 0 (this device) | K990704 | Array 360 System C-Reactive Protein (CRP Mpe) Reagent | Beckman Coulter, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) ReagentSummary page 1…munological test system (21 CFR § 866.5270) 4.0 Predicate Device(s): Predicate Manufacturer Docket Number Array® 360 System C- | IMMAGE System C- Beckman Coulter, Inc. | K981638 Reactive Protein Reactive Protein (CRP) (CRPwpe) Reagent Reagent 5.0 Description: The Array 360 System (CRPweg) reagent, in conju… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K981638.
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?
C-Reactive Protein (CRPyre) Reagent, when used in conjunction with Beckman Coulter's Array® 360 System and Calibrator 5 Plus, is intended for the quantitative determination of human C-reactive protein in serum or plasma by rate nephelometry.
Clinical Significance:
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/K990704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990704: Array 360 System C-Reactive Protein (CRP Mpe) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990704
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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