510(k) Report

510(k) · Cleared

Cleared

Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP (600 Tests)

K071017510(k) SpecialCleared May 2, 200722-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

Siemens Medical Solutions Diagnostics · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on May 2, 2007 as substantially equivalent to K063057 (Diagnostic Products Corporation, 2006) and 1 other predicate after a 22-day review. Its family tree reaches back 3 generations to 1999.

Decided
May 2, 2007
Review
22 days
Class
Class II
Product code
NQD
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K991385 (1999). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 1999K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 2004K063057 · Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP · Diagnostic Products Corporation · 20061996199820002002200420062008
Other ancestors, by generation 1 generation back: 1 other ancestor K063057 · Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP · Diagnostic Products Corporation · 2006K033908 · N High Sensitivity CRP · Dade Behring, Inc. · 2004K991385 · Dade Behring N High Sensitivity CRP Assay · Dade Behring, Inc. · 19990
  1. Root · 3 generations backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
  2. 2 generations backK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
  3. 1 generation backK063057 Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation · 2006
  4. This deviceK071017 Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP…Siemens Medical Solutions Diagnostics · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K991385Dade Behring N High Sensitivity CRP AssayDade Behring, Inc.1999—
−2K033908N High Sensitivity CRPDade Behring, Inc.2004—
−1K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation2006—
0 (this device)K071017Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests)…Siemens Medical Solutions Diagnostics2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K071017, 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
*K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP
Summary page 2
…tration #: 3005250747 Substantially Equivalent Predicate Device: IMMULITE 2000 High Sensitivity C-Reactive Protein Immunoassay (K063057, K003372) Description of Device: The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassay is…
Diagnostic Products Corporation2006—
*K003372Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP
Summary page 2
…: 3005250747 Substantially Equivalent Predicate Device: IMMULITE 2000 High Sensitivity C-Reactive Protein Immunoassay (K063057, K003372) Description of Device: The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassay is…
Diagnostic Products Corp.2000—

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 3 companies; a new generation was cleared every 2.9 years on median.
  • None of the 4 ancestors has a recall.

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?

The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 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 (112 words)

The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2500 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.

More from Siemens Medical Solutions Diagnostics

11 FDA decisions under this applicant name. See the company

  • K100910Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2011
  • K091984Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2009
  • K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 20092 recalls
  • K071455Advia Centaur Cyclosporine Assay and CalibratorSiemens Medical Solutions Diagnostics · 20081 recall
  • K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 20087 recalls

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/K071017 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071017: Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP (600 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071017

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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