510(k) · Cleared
Recalled · Class II · 2025Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Jul 31, 1995 after a 21-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 31, 1995
- Review
- 21 days
- Class
- Class II
- Product code
- DCK
- Recalls
- 3
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK953197 Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)Johnson & Johnson Clinical Diagnostics, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK041799 Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK030626 Vitros Chemistry Products CRP Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK152433 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products…Ortho Clinical Diagnostics · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK141689 FastPack High Sensitivity C-Reactive Protein Immunoassay, High…Qualigen, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK042838 Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K041799Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly2descendants
- K030626Vitros Chemistry Products CRP Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc. · 2003 · cites it directly1descendant
- K152433VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7Ortho Clinical Diagnostics · 2015 · 2 generations on0descendants
- K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc. · 2015 · 2 generations on0descendants
- K042838Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…Ortho-Clinical Diagnostics, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995 | — |
| +1 | K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| +1 | K030626 | Vitros Chemistry Products CRP Slide and Calibrator Kit 7 | Ortho-Clinical Diagnostics, Inc. | 2003 | 3 |
| +2 | K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | 2015 | 3 |
| +2 | K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity… | Qualigen, Inc. | 2015 | — |
| +2 | K042838 | Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2015 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041799 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K953197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953197: Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953197
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026