510(k) · Cleared
ClearedCRP Diagnostic Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Ch. Srl · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Aug 8, 2005 as substantially equivalent to K030545 (Denka Seiken Co., Ltd., 2003) and 3 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.
- Decided
- Aug 8, 2005
- Review
- 129 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K860894 (1986). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK050836 CRP Diagnostic AssaySentinel Ch. Srl · 2005
- Descendant · cites it directly · 0 of its ownK192118 CRP VarioSENTINEL CH. SpA · 2019
Most influential descendants
Showing 1 of 1 · See all- K192118CRP VarioSENTINEL CH. SpA · 2019 · cites it directly0descendants
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) | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
| +1 | K192118 | CRP Vario | SENTINEL CH. SpA | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K030545 | CRP-Latex (II)X2 Seiken Assay KitSummary page 3…devices. Table 7.1 Predicate devices for Sentinel CRP DIAGNOSTIC ASSAY devices 6CRP Vario CRP-Latex (II)X2 Denka Seiken Co. k030545 6 Feb. 2003 SEIKEN 7 CRP Calibrator Set CRP(ll) Calibrators Denka Sei… | 2003 |
| * | K030546 | CRP (II) CalibratorsSummary page 3…k030545 6 Feb. 2003 SEIKEN 7 CRP Calibrator Set CRP(ll) Calibrators Denka Seiken Co. k030546 6 Feb. 2003 CRP Calibrator US 8 used with CRP CRP(II) Calibrators Denka Seiken Co.… | 2003 |
| * | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) ReagentSummary page 3…6 Feb. 2003 Calibrator Set CRP Calibrator WR Immage 9 used with CRP Immunochemistry Beckman Coulter, k981638 6 Dec. 1998 Calibrator Set System CRP Inc. reage… | 1998 |
| * | K011169 | Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3Summary page 3…System CRP Inc. reagent 1OCRP Control US hsCRP Control CLINIQA k011169 18 May 2001 Level1 The Sentinel's CRP reagents, calibrators and control and the… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192118 | CRP Vario | 2019 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K192118 (SENTINEL CH. SpA, 2019) has gone furthest, with 0 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?
CRP Calibrators (CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum and EDTA or lithium heparinized plasma samples.
CRP Varlo is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.
CRP Control US is intended for use as an assayed quality control material for serum C-reactive protein analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050836: CRP Diagnostic Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050836
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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