510(k) · Cleared
Recalled · Class II · 2013Vitros Chemistry Products CRP Slide and Calibrator Kit 7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Mar 18, 2003 as substantially equivalent to K953197 (Johnson & Johnson Clinical Diagnostics, Inc., 1995) after a 19-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Mar 18, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- DCK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953197 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK953197 Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)Johnson & Johnson Clinical Diagnostics, Inc. · 1995 · Recalled
- This deviceK030626 Vitros Chemistry Products CRP Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK152433 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products…Ortho Clinical Diagnostics · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152433VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7Ortho Clinical Diagnostics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995 | 3 |
| 0 (this device) | K030626 | Vitros Chemistry Products CRP Slide and Calibrator Kit 7 | Ortho-Clinical Diagnostics, Inc. | 2003 | — |
| +1 | K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | 2015 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)Summary page 3…Chemistry Products Calibrator Kit 7 which were cleared by the FDA for in vitro diagnostic use with human serum and plasma. (K953 197, cleared July 3 1, 1995) Table 1 lists the characteristics of the tests performed using the Vitrus… | 1995 |
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 |
|---|---|---|---|
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2013 | Class II | Z-0309-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| Nov 22, 2004 | Not classified | Z-0387-05 | Other | Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range. |
| Jul 28, 2004 | Not classified | Z-1473-04 | Other | The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Vitros Chemistry Products CRP Slides
For in vitro diagnostic use only.
Vitros Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma.
Vitros Chemistry Products Calibrator Kit 7
For in vitro diagnostic use only.
Vitros Calibrator Kit 7 is intended for use in the calibration of the Yitros Chemistry Systems for the quantitative measurement of CRP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030626 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030626: Vitros Chemistry Products CRP Slide and Calibrator Kit 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030626
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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