510(k) Report

510(k) · Cleared

Cleared

Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP

K003372510(k) TraditionalCleared Dec 26, 200057-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 Corp. · DCN System, Test, C-Reactive Protein

Cleared on Dec 26, 2000 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 26, 2000
Review
57 days
Class
Class II
Product code
DCN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared200020052010201520202025
  1. This deviceK003372 Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRPDiagnostic Products Corp. · 2000
  2. 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
0 (this device)K003372Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRPDiagnostic Products Corp.2000—
+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 K003372, 2000–2007Source: 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), 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? (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?

  • Of its descendants, K071017 (Siemens Medical Solutions Diagnostics, 2007) has gone furthest, with 0 descendants 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 Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

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/K003372 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003372: Immulite High Sensitivity CRP, 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/K003372

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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