510(k) Report

510(k) · Cleared

Cleared

Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP

K063057510(k) AbbreviatedCleared Dec 22, 200678-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

Diagnostic Products Corporation · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Dec 22, 2006 as substantially equivalent to K991385 (Dade Behring, Inc., 1999) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.

Decided
Dec 22, 2006
Review
78 days
Class
Class II
Product code
NQD
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K991385 (1999). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant clearedK991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 1999K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 20041995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant 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 deviceK063057 Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation · 2006
  4. Descendant · cites it directly · 0 of its ownK071017 Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP…Siemens Medical Solutions Diagnostics · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K071017Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…Siemens Medical Solutions Diagnostics · 2007 · cites it directly0descendants
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)K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation2006—
+1K071017Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests)…Siemens Medical Solutions Diagnostics2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K063057, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K991385Dade Behring N High Sensitivity CRP Assay
Summary page 2
…372. A summary of the features of the IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assay and the predicate device, Dade Behring N High Sensitivity CRP, (K991385/K033908) is presented below. Item IMMULITE/IMMULITE 1000 and Dade Behring N…
Dade Behring, Inc.1999—
*K033908N High Sensitivity CRP
Summary page 2
…ummary of the features of the IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assay and the predicate device, Dade Behring N High Sensitivity CRP, (K991385/K033908) is presented below. Item IMMULITE/IMMULITE 1000 and Dade Behring N High Sen…
Dade Behring, Inc.2004—

Also cleared against K991385: 7 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K071017Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…Siemens Medical Solutions Diagnostics20070

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 7 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K071017 (Siemens Medical Solutions Diagnostics, 2007) has gone furthest, with 0 descendants of its own.
  • 7 other devices also cite its predicate K991385.

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.

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?

The IMMULITE®/IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future…

Read the full statement (221 words)

The IMMULITE®/IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

MMULITE® 2000 High Sensitivity CRP assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease, High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

Indications for use as stated in the FDA summary.

Also cleared against K991385

7 other devices cite the same predicate.

  • K033908N High Sensitivity CRPDade Behring, Inc. · 2004
  • K032663Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls VE Controls 1/2Instrumentation Laboratory CO · 2003
  • K030899C-Reactive Protein (CRP)Abbott Laboratories · 2003
  • K030545CRP-Latex (II)X2 Seiken Assay KitDenka Seiken Co., Ltd. · 20031 recall
  • K023269Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity ControlsInstrumentation Laboratory CO · 2002
  • K011855Wampole HS-CRP ElisaCarter-Wallace, Inc. · 2002

More from Diagnostic Products Corporation

3 FDA decisions under this applicant name. See the company

  • K060929Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200…Diagnostic Products Corporation · 2006
  • K053533Immulite/Immulite 1000 Turbo Intact PTHDiagnostic Products Corporation · 2006

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/K063057 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063057: Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063057

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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