510(k) · Cleared
ClearedCRP Vario
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SENTINEL CH. SpA · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Nov 8, 2019 as substantially equivalent to K050836 (Sentinel Ch. Srl, 2005) after a 94-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Nov 8, 2019
- Review
- 94 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K860894 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- 3 generations backK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
- 2 generations backK981638 Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc. · 1998 · Recalled
- 1 generation backK050836 CRP Diagnostic AssaySentinel Ch. Srl · 2005
- This deviceK192118 CRP VarioSENTINEL CH. SpA · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| −3 | K962523 | N Latex CRP Mono Reagent | Behring Diagnostics, Inc. | 1996 | — |
| −2 | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) Reagent | Beckman Coulter, Inc. | 1998 | 1 |
| −1 | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K050836 | CRP Diagnostic AssaySummary page 5…a modification of the predicate device. The device name, CRP Vario, is unchanged from how it was cleared in 510(k) k050836 on August 8th, 2005 and CLIA categorized on October 1st,2008 Establishment The Establishm… | 2005 |
| † | K051564 | Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026… | 2005 |
| † | K112412 | AU5800(R) Chemistry Analyzer | 2011 |
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 33 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
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. 2019, this device’s year, is highlighted.
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 CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.
CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR):
CRP Calibrators are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum or plasma samples.
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/K192118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192118: CRP Vario.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192118
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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