510(k) Report

510(k) · Cleared

Recalled · 2008

RCRP Flex Reagent Cartridge

K003419510(k) TraditionalCleared Feb 14, 2001104-day reviewClass II21 CFR 866.5270Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · DCN System, Test, C-Reactive Protein

Cleared on Feb 14, 2001 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided
Feb 14, 2001
Review
104 days
Class
Class II
Product code
DCN
Recalls
1
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2023: 2 descendants cleared200020052010201520202025
  1. This deviceK003419 RCRP Flex Reagent CartridgeDade Behring, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK221119 RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 2023 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK232624 CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 2023 · cites it directly1descendant
  • K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003419RCRP Flex Reagent CartridgeDade Behring, Inc.2001—
+1K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.20232
+2K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
FIG. 1 — Lineage of K003419, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DCN? 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 DCN device

  1. #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.20231

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 15, 2008Not classifiedZ-1930-2009Labeling False and Misleadingfalsely elevated results in EDTA plasma samples

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K221119 (Siemens Healthcare Diagnostics, Inc., 2023) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DCN devices

DCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCN

2in 2023

2007: 12008: 22009: 32010: 12012: 12017: 12018: 32020: 12023: 2
2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCN

234in 2018

2009: 111 days median2018: 234 days median
2007high 234 (2018) · low 111 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DCN

1in 2020

2008: 12019: 12020: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DCN

7in 2025

2010: 22011: 52012: 22014: 22015: 22016: 12018: 22019: 82021: 12022: 12023: 32024: 52025: 7
2007high 8 (2019) · low 0 (2007)2025

MAUDE reports naming product code DCN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20082—10
2009311100
20101—02
20110—05
20121—02
20130—00
20140—02
20150—02
20160—01
20171—00
2018323402
20190—18
20201—10
20210—01
20220—01
20232—03
20240—05
20250—07
20260—1—

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in DCN

The DCN category page

  • K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023
  • K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 20232 recalls
  • K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo) · 2020
  • K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd. · 2018
  • K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein…The Binding Site Group, Ltd. · 20181 recall

https://510kreport.com/device/K003419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003419: RCRP Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003419

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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