IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

K963061 · Beckman Instruments, Inc. · DCK · Nov 4, 1996 · Immunology

Device Facts

• Record ID: K963061
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DCK · Immunology
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.

Device Story

The IMMAGE Immunochemistry System CRP reagent is an in vitro diagnostic assay used for the quantitative measurement of C-reactive protein in human serum and plasma. The device utilizes rate nephelometry and latex particle-enhanced immunochemistry to detect CRP concentrations. It is designed for operation on the Beckman IMMAGE Immunochemistry System in a clinical laboratory setting by trained laboratory personnel. The system processes samples to produce a quantitative concentration value, which is reported to the healthcare provider. This output assists clinicians in evaluating inflammatory states in patients. The reagent is provided in a liquid stable form, offering improved stability compared to lyophilized alternatives.

Clinical Evidence

Bench testing only. Method comparison study against Behring N Latex CRP (n=not specified) yielded a slope of 1.037, intercept of -0.06, and correlation coefficient (r) of 0.991. Imprecision studies demonstrated within-run %CVs ranging from 1.8% to 8.1% across three concentration levels (1.65–12.6 mg/dL). Stability data confirms a 24-month shelf-life and 14-day open-container/calibration stability.

Technological Characteristics

Latex particle-enhanced immunochemistry; rate nephelometry detection principle. Reagent is liquid stable. Uses goat-derived antibodies. Designed for use on the IMMAGE Immunochemistry System. No specific ASTM material standards or connectivity protocols provided.

Indications for Use

Indicated for the quantitative determination of C-reactive protein (CRP) in human serum and plasma samples to aid in the assessment of inflammation.

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

• Behring N Latex CRP

Submission Summary (Full Text)

{0}

200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]

NOV - 4 1996

BECKMAN

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent

K963061

Revised

Dmc: Dated 10/4/96

1.0 Submitted By:

Annette Hellie
Regulatory Specialist, Product Submissions
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

2.0 Date Submitted:

06 Aug-1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent

3.2 Classification Names

C-reactive protein immunological test system(21 CFR 866.5270)

4.0 Predicate Device(s):

Behring N Latex CRP

5.0 Description:

The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples.

6.0 Intended Use:

The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.

file: irf510k.see

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent
Summary of Safety & Effectiveness

# 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SIMILARITIES | | |
| IMMAGE System (CRP) Reagent | Intended Use | Same as Behring N Latex CRP |
| | Nephelometric methodology | Same as Behring N Latex CRP |
| | Use of Latex particle technology | Same as Behring N Latex CRP |
| DIFFERENCES | | |
| IMMAGE System (CRP) Reagent | Form of reagent | the IMMAGE CRP is liquid stable while Behring N Latex CRP reagent is lyophilized |
| | Antibody source | IMMAGE CRP uses goat while Behring N Latex CRP uses rabbit. |
| | Stability | IMMAGE CRP is stable for 14 days once opened, properly stored while Behring N Latex CRP reagent is stable for one week following reconstitution,. |

file: crp510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent
Summary of Safety & Effectiveness
3

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Behring N Latex CRP Reagent to the IMMAGE CRP Reagent.

### Method Comparison Study Results
IMMAGE CRP Reagent vs. Behring N Latex CRP Reagent

| Analyte | Slope | Intercept | r | Predicate |
| --- | --- | --- | --- | --- |
| IMMAGE CRP | 1.037 | -0.06 | 0.991 | Behring N Latex CRP |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE CRP | 24 month shelf-life
14 day open container stability
14 day calibration stability |

### Estimated Within-Run Imprecision

| MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| CRP Reagent | | | | |
| Level 1 | 1.65 | 0.134 | 8.1 | 80 |
| Level 2 | 5.41 | 0.165 | 3.1 | 80 |
| Level 3 | 12.6 | 0.22 | 1.8 | 80 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

file: crp510k.sse