510(k) · Cleared
ClearedProcise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procise Diagnostics · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Nov 4, 2022 as substantially equivalent to K142993 (Orion Diagnostica, OY, 2016) after a 907-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Nov 4, 2022
- Review
- 907 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K142993 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK142993 QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP…Orion Diagnostica, OY · 2016
- This deviceK201256 Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control… | Orion Diagnostica, OY | 2016 | — |
| 0 (this device) | K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | Procise Diagnostics | 2022 | — |
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
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 |
|---|---|---|---|
| * | K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…Summary page 4…rietary Names ProciseDx Analyzer Procise C-Reactive Protein Procise CRP ProciseDx Calibration Cartridge 3. Predicate Orion Diagnostica QuikRead go CRP K142993 4. Device Description The Procise CRP assay is a homogeneous sandwich immunoassay assay that uses a fluorescence resonance… | 2016 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K142993.
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. 2022, 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 Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of
C-Reactive Protein (CRP) levels in human scrum. The test is carried out by means of the ProciseDx Analyzer.
Measurement of CRP aids in evaluation of injury to body tissues, infection, and inflammatory disorders. The instrument
and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point of
care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201256: Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201256
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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