N HIGH SENSITIVITY CRP

K033908 · Dade Behring, Inc. · NQD · Jan 22, 2004 · Immunology

Device Facts

• Record ID: K033908
• Device Name: N HIGH SENSITIVITY CRP
• Applicant: Dade Behring, Inc.
• Product Code: NQD · Immunology
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Indications for Use

N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, 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 syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Device Story

In vitro diagnostic reagent for quantitative CRP measurement in human serum/plasma. Uses particle-enhanced immunonephelometry on BN™ Systems; polystyrene particles coated with anti-CRP monoclonal antibodies agglutinate in presence of CRP; scattered light intensity measured by nephelometer correlates to CRP concentration. Used in clinical laboratories by trained personnel. Output provides CRP concentration levels to clinicians; aids in assessing infection, inflammation, and cardiovascular risk/prognosis. Benefits include improved prognostic assessment for patients with stable coronary disease or acute coronary syndromes.

Clinical Evidence

No new clinical trials performed. Substantial peer-reviewed literature and AHA/CDC expert panel recommendations provided to support the additional cardiac risk assessment claim. Analytical performance (precision, linearity, detection limit, specificity) established by reference to predicate K991385.

Technological Characteristics

Polystyrene particles coated with monoclonal antibodies to CRP. Principle: particle-enhanced immunonephelometry. Standardized against IFCC/BCR/CAP reference preparation (CRM 470). System: BN™ Systems. Reagent-based assay.

Indications for Use

Indicated for quantitative determination of C-reactive protein (CRP) in human serum, heparin plasma, and EDTA plasma. Used for detection/evaluation of infection, tissue injury, inflammatory disorders, and as an aid in identifying individuals at risk for future cardiovascular disease. Used as an independent prognostic marker for recurrent events in patients with stable coronary disease or acute coronary syndromes.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• N High Sensitivity CRP (K991385)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033908

B. Analyte:
CRP (high sensitivity)

C. Type of Test:
Quantitative

D. Applicant:
Dade Behring, Inc.

E. Proprietary and Established Names:
N High Sensitivity CRP

F. Regulatory Information:
1. Regulation section:
21 CFR 866.5270
2. Classification:
Class II
3. Product Code:
NQD
4. Panel:
82 Immunology

G. Intended Use:
1. Intended use(s):
N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN Systems.
2. Indication(s) for use:
In acute phase response, increased levels of a number of plasma proteins including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, 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 syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
3. Special condition for use statement(s):
None
4. Special instrument Requirements:
BN Systems (nephelometry)

H. Device Description:

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The Dade N High Sensitivity CRP is an immunonephelometric assay. Polystyrene particles coated with monoclonal antibodies to CRP are agglutinated when mixed with samples containing CRP. The intensity of the scattered light in the nephelometer depends on the CRP content of the sample and therefore the CRP concentration can be determined versus dilutions of a standard of a known concentration. Results are reported in mg/L.

# I. Substantial Equivalence Information:

1. Predicate device name(s):

N High Sensitivity CRP

2. Predicate K number(s):

K991385

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Specimen type | Serum, heparin- or EDTA plasma | Same |
| Instrumentation | BN Systems | Same |
| Precision | Same | Same |
| Sensitivity | Same | Same |
| Performance | Same | Same |
| Differences | | |
| Item | Device | Predicate |
| Intended use | Cardiac risk assessment and injury/inflammation | Injury/inflammation |

# J. Standard/Guidance Document Referenced (if applicable):

AHA/CDC Scientific Statement (Circulation, 2003; 107:499-511)

# K. Test Principle:

Immunonephelometry

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

By reference to K991385

b. Linearity/assay reportable range:

By reference to K991385

c. Traceability (controls, calibrators, or method):

CRM 470

d. Detection limit:

By reference to K991385

e. Analytical specificity:

By reference to K991385

f. Assay cut-off:

By reference to K991385

2. Comparison studies:

a. Method comparison with predicate device:

N/A. Device is the same as predicate but seeks new claim.

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b. Matrix comparison:
By reference to K991385

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):
Substantial peer-reviewed literature using the Dade test was provided to support clinical cardiac claims. A recent AHA/CDC expert panel recommendation statement using evidence-based processes concluded that cardiac claims were appropriate

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
Relative risk/average hsCRP:
Low <1 mg/L
Average 1.0-3.0 mg/L
High >3.0 mg/L

M. Conclusion:
This device is substantially equivalent to K991385 N High Sensitivity CRP with an additional cardiac risk assessment claim supported by peer-reviewed literature and professional statements.