510(k) · Cleared
ClearedAbx Pentra 400 : CRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Sep 29, 2006 as substantially equivalent to K023828 (Kamiya Biomedical Co., 2003) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 29, 2006
- Review
- 158 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022486 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK022486 K-Assay HS-CRP ControlsKamiya Biomedical Co. · 2002
- This deviceK061138 Abx Pentra 400 : CRPHoriba Abx · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022486 | K-Assay HS-CRP Controls | Kamiya Biomedical Co. | 2002 | — |
| 0 (this device) | K061138 | Abx Pentra 400 : CRP | Horiba Abx | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…Summary page 2…ISubstantially equivalent Submission device Predicate device ABX PENTRA CRP CP K023828 ABX PENTRA CRP Cal K023828 ABX PENTRA Immuno I Control L/H… | 2003 |
| * | K022486 | K-Assay HS-CRP ControlsSummary page 2…K023828 ABX PENTRA CRP Cal K023828 ABX PENTRA Immuno I Control L/H K022486 ABX PENTRA Low CRP Control K022486 HORIBA ABX, FRANCE… | 2002 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K023828.
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?
CRP reagent, with associated calibrators and controls, are intended for use on ABX -. ,PE!Z Jmgc,¢_c' sAnalyzer to measure C-reactive Protein analyte. The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method. ABX…
Read the full statement (140 words)
CRP reagent, with associated calibrators and controls, are intended for use on ABX -. ,PE!Z Jmgc,¢_c' sAnalyzer to measure C-reactive Protein analyte.
The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method.
ABX PENTRA CRP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.
The ABX PENTRA Immuno I Control L/H is for use in quality control by monitoring accuracy and precision for CRP.
Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061138: Abx Pentra 400 : CRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061138
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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