510(k) · Cleared
ClearedHemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Dec 23, 2002 as substantially equivalent to K991385 (Dade Behring, Inc., 1999) after an 83-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Dec 23, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991385 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- This deviceK023269 Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity…Instrumentation Laboratory CO · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K023269 | Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls | Instrumentation Laboratory CO | 2002 | — |
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 |
|---|---|---|---|
| * | K991385 | Dade Behring N High Sensitivity CRP AssaySummary page 1…Reactive Protein Immunological Test System Class I1 81DCK C-Reactive Protein, Antigen, Antiserum, and Control Identification of predicate device(s): K991385 N High Sensitivity CRP Description of the devicehntended use(s): HemosIL High Sensitivity - C Reactive Protein is an… | 1999 |
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?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K991385.
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?
HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023269: Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023269
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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