510(k) · Cleared
ClearedQuantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls VE Controls 1/2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Dec 19, 2003 as substantially equivalent to K991385 (Dade Behring, Inc., 1999) after a 113-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Dec 19, 2003
- Review
- 113 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991385 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- This deviceK032663 Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High…Instrumentation Laboratory CO · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K032663 | Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity… | Instrumentation Laboratory CO | 2003 | — |
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 |
|---|---|---|---|
| * | K991385 | Dade Behring N High Sensitivity CRP AssaySummary page 1…Reactive Protein Immunological Test System Class II DCK C-Reactive Protein, Antigen, Antiserum, and Control Identification of predicate device(s): K991385 N High Sensitivity CRP Description of the device/intended use(s): Quantex CRP High Sensitivity is intended as a latex… | 1999 |
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.
- 7 other devices also cite its predicate K991385.
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?
Quantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032663: Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls VE Controls 1/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032663
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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