510(k) Report

510(k) · Cleared

Cleared

Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent

K071002510(k) TraditionalCleared Jun 21, 200773-day reviewClass II21 CFR 866.5270

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

Beckman Coulter, Inc. · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Jun 21, 2007 as substantially equivalent to K033908 (Dade Behring, Inc., 2004) and 2 other predicates after a 73-day review. Its family tree reaches back 2 generations to 1999.

Decided
Jun 21, 2007
Review
73 days
Class
Class II
Product code
NQD
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K991385 (1999). 4 ancestors in all, the oldest K926236 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1993: 1 other ancestorK991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 1999K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 20041990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 2004K991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 19990
  1. Root · 2 generations backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
  2. 1 generation backK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
  3. This deviceK071002 Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive…Beckman Coulter, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K991385Dade Behring N High Sensitivity CRP AssayDade Behring, Inc.1999—
−1K033908N High Sensitivity CRPDade Behring, Inc.2004—
0 (this device)K071002Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein…Beckman Coulter, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
200110
FIG. 1 — Lineage of K071002, 1999–2007Source: 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), 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 NQD? 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 NQD device

  1. #1 K260026 Tina-quant Cardiac high sensitivity CRP IIIscore 12.3 · 5 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K033908N High Sensitivity CRP
Summary page 1
…Number IMMAGE Immunochemistry Dade Behring Dade Behring K033908 Systems High Sensitivity CbrdioPhase hsCRP Inc.* Cardiac CCRP Reagent IMMAGE Immunoc…
Dade Behring, Inc.2004—
*K010236Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) Reagent
Summary page 1
…K033908 Systems High Sensitivity CbrdioPhase hsCRP Inc.* Cardiac CCRP Reagent IMMAGE Immunochemistry Beckman K010236 Systems High Sensitivity Coulter, Inc CRPH Re…
Beckman Coulter, Inc.2001—
*K926236Beckman Anti-Streptolysin O Kit
Summary page 1
…Sensitivity Coulter, Inc CRPH Reagent Beckman CAL 5 Plus Beckman Cal 5 Plus Beckman K926236/A Coulter, Inc. *Dade Behring Inc. (Newark, DE) 5.0…
Beckman Instruments, Inc.19931

Also cleared against K033908: 10 other devices →

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?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 10 other devices also cite its predicate K033908.

How does its category compare?

All NQD devices

NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NQD

1in 2024

2007: 32008: 12018: 12022: 12024: 12026 (partial year): 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQD

59in 2007

2007: 59 days median
2007high 59 (2007)2026

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

Recalls per year · NQD

2in 2015

2015: 2
2007high 2 (2015) · low 0 (2007)2026

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

Adverse event reports per year · NQD

2in 2025

2007: 12010: 12011: 52012: 22016: 12017: 12021: 22023: 22024: 12025: 2
2007high 5 (2011) · low 0 (2008)2025

MAUDE reports naming product code NQD, 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
200735901
20081—00
20090—00
20100—01
20110—05
20120—02
20130—00
20140—00
20150—20
20160—01
20170—01
20181—00
20190—00
20200—00
20210—02
20221—00
20230—02
20241—01
20250—02
20261—0—

What is it indicated for?

High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry. Clinical Significance: Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated…

Read the full statement (150 words)

High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with

IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative

determination of C-Reactive protein in human serum or plasma by rate turbidimetry.

Clinical Significance:

Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection,

inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid

in the identification and stratification of individuals at risk for future cardiovascular disease. When

used inconjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP

may be useful as an independent marker of prognosis for recurrent events in patients with stable

coronary disease or acute coronary syndrome.

CAL 5 Plus (Calibrator 5 Plus), when used in conjunction with Beckman Coulter reagents, is

intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin

0 (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).

Indications for use as stated in the FDA summary.

Also cleared against K033908

10 other devices cite the same predicate.

  • K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022
  • K081294Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc. · 20082 recalls
  • K070626Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentBeckman Coulter, Inc. · 2007
  • K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation · 2006
  • K061802Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp Control Low, Hscrp 1…Dade Behring, Inc. · 2006
  • K061825Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control HighDade Behring, Inc. · 2006

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in NQD

The NQD category page

  • K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics · 2026
  • K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc. · 2024
  • K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022
  • K173833CRP VarioSENTINEL CH. SpA · 2018
  • K081294Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc. · 20082 recalls

https://510kreport.com/device/K071002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071002: Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071002

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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