510(k) · Cleared
Recalled · Class II · 2025VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Sep 24, 2015 as substantially equivalent to K030626 (Ortho-Clinical Diagnostics, Inc., 2003) after a 28-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 3 times.
- Decided
- Sep 24, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- DCK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953197 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK953197 Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)Johnson & Johnson Clinical Diagnostics, Inc. · 1995 · Recalled
- 1 generation backK030626 Vitros Chemistry Products CRP Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc. · 2003 · Recalled
- This deviceK152433 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products…Ortho Clinical Diagnostics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995 | 3 |
| −1 | K030626 | Vitros Chemistry Products CRP Slide and Calibrator Kit 7 | Ortho-Clinical Diagnostics, Inc. | 2003 | 3 |
| 0 (this device) | K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | 2015 | — |
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 |
|---|---|---|---|
| * | K030626 | Vitros Chemistry Products CRP Slide and Calibrator Kit 7Summary page 4…hemistry Products CRP Slides and claimed VITROS Chemistry Products Calibrator Kit 7 (current), cleared March, 2003 (K030626). Ortho-Clinical Diagnostics, Inc. Page 1 of 7 August 26, 2015 VIT… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2025 | Class II | Z-1876-2025 | Process control | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. |
| Oct 11, 2024 | Class II | Z-0535-2025 | Under Investigation by firm | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample… |
| Oct 26, 2016 | Class III | Z-0864-2017 | Process control | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 2 of the 2 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. 2015, 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?
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 using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. C-reactive protein is synthesized by the liver and is one of the acute phase proteins. In the acute phase response, increased concentrations of a number of plasma proteins…
Read the full statement (130 words)
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 using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
C-reactive protein is synthesized by the liver and is one of the acute phase proteins. In the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections.
VITROS Chemistry Products Calibrator Kit 7:
For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152433: VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152433
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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