510(k) Report

510(k) · Cleared

Cleared

Nanopia Wide Range C-Reactive Protein (CRP) Reagent Kit

K052591510(k) TraditionalCleared Feb 9, 2006141-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

Clinical Data, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Feb 9, 2006 as substantially equivalent to K040241 (Genzyme Corp., 2004) after a 141-day review. Its family tree reaches back 1 generation to 2004.

Decided
Feb 9, 2006
Review
141 days
Class
Class II
Product code
DCK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K040241 (2004). No later device cites it as a predicate yet.

K040241 · N-Geneous Wide Range CRP Reagent and Calibrator Set · Genzyme Corp. · 200420002002200420062008
K040241 · N-Geneous Wide Range CRP Reagent and Calibrator Set · Genzyme Corp. · 20040
  1. Root · 1 generation backK040241 N-Geneous Wide Range CRP Reagent and Calibrator SetGenzyme Corp. · 2004
  2. This deviceK052591 Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitClinical Data, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040241N-Geneous Wide Range CRP Reagent and Calibrator SetGenzyme Corp.2004—
0 (this device)K052591Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitClinical Data, Inc.2006—
FIG. 1 — Lineage of K052591, 2004–2006Source: 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 DCK? 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 DCK device

  1. #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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
*K040241N-Geneous Wide Range CRP Reagent and Calibrator Set
Summary page 2
…analyzers. H. Substantial Equivalence Information: 1. Predicate device name(s): N-Geneous Wide Range CRP Reagent. 2. Predicate K number(s): K040241 Page 3 of 6 3. Comparison wi…
Genzyme Corp.2004—

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?

  • Its one ancestor has no recall.

How does its category compare?

All DCK devices

DCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCK

1in 2025

2011: 12012: 12015: 22016: 12017: 12019: 22020: 12022: 12025: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCK

Too few DCK 510(k)s in any year since 2007 to give a median.

Recalls per year · DCK

1in 2024

2008: 12009: 12013: 12016: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DCK

1in 2021

2008: 12011: 12012: 12014: 12021: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code DCK, 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
20070—00
20080—11
20090—10
20100—00
20111—01
20121—01
20130—10
20140—01
20152—00
20161—10
20171—00
20180—00
20192—00
20201—00
20210—01
20221—00
20230—00
20240—10
20251—00
20260—0—

What is it indicated for?

The Nanopia Wide Range CRP Reagent is intended for the quantitative measurement of C-Reactive Protein (CRP) in serum or plasma. The assay is intended for use in the evaluation of infection, tissue injury, and inflammatory disorders in combination with a complete clinical evaluation.

Indications for use as stated in the FDA summary.

More from Clinical Data, Inc.

36 FDA decisions under this applicant name. See the company

  • K071706Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)Clinical Data, Inc. · 2007
  • K033983Vitalab Iron ReagentClinical Data, Inc. · 2004
  • K040631Vitalab Direct Bilirubin ReagentClinical Data, Inc. · 2004
  • K040534Vitalab Amylase ReagentClinical Data, Inc. · 2004
  • K034000Vitalab Triglycerides Reagent and Vitalab CalibratorClinical Data, Inc. · 2004

Recent decisions in DCK

The DCK category page

  • K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC · 2025
  • K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics · 2022
  • K192028Yumizen C1200 CRPHoriba Abx Sas · 2020
  • K192118CRP VarioSENTINEL CH. SpA · 2019
  • K191993Yumizen C1200 CRPHoriba Abx Sas · 2019

https://510kreport.com/device/K052591 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052591: Nanopia Wide Range C-Reactive Protein (CRP) Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052591

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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