N LATEX CRP MONO REAGENT

K962523 · Behring Diagnostics, Inc. · DCK · Jul 10, 1996 · Immunology

Device Facts

• Record ID: K962523
• Device Name: N LATEX CRP MONO REAGENT
• Applicant: Behring Diagnostics, Inc.
• Product Code: DCK · Immunology
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.

Device Story

In vitro diagnostic reagent for quantitative CRP determination in human serum; used with Behring Nephelometer Systems. Principle: particle-enhanced nephelometry; polystyrene particles coated with mouse monoclonal anti-CRP antibodies agglutinate in presence of CRP; scattered light intensity measured by nephelometer; intensity proportional to CRP concentration. Comparison to known standards allows quantification. Used in clinical laboratory settings by trained personnel. Output: CRP concentration (mg/L). Assists clinicians in evaluating inflammatory states.

Clinical Evidence

Bench testing only. Correlation study (n=71 serum samples) between N Latex CRP mono and predicate yielded r=0.98, slope=0.95, y-intercept=1.43. Intra-assay precision (n=20) at 15, 25, 60 mg/L showed CVs of 4.0%, 2.3%, and 4.4%. Inter-assay reproducibility (n=10) at 10, 15, 25, 45, 60 mg/L showed CVs ranging from 2.6% to 5.7%.

Technological Characteristics

Liquid reagent; polystyrene particles coated with mouse monoclonal anti-CRP antibodies. Measurement via nephelometry (light scattering). Measuring range: 0.175–1100 mg/L. Calibrated via lot-independent standard.

Indications for Use

Indicated for the quantitative determination of C-reactive protein (CRP) in human serum 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

• N Latex CRP (K860894)

Submission Summary (Full Text)

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K962523

JUL 10 1996

Attachment 1

510(k) Summary of Safety and Effectiveness for N Latex CRP mono Reagent

1. Manufacturer Name, Adress, phone number, contact name and date of preparation:

Manufacturer: Behringwerke AG,
Postfach 1140
35001 Marburg
Germany

Distributor: Behring Diagnostics Inc.
151 University Avenue
Westwood, MA 02090
617 - 320 - 3023
Contact name: Kathleen Dray-Lyons

date of preparation: May 29, 1996

2. Device name/Classification:

In vitro diagnostic reagents for the quantitative determination of C-reactive protein (CRP) Class II (866.5270).

3. Identification of the legally marketed device to which the submitter claims equivalence:

The Behringwerke N Latex CRP (K860894)

4. Proposed Device Description:

The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.

In the proposed product polystyrene particles coated with mouse monoclonal antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.

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5. Proposed Device Intended Use:

The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.

6. Medical device to which equivalence is claimed and comparison information:

The N Latex CRP mono Reagent is substantially equivalent in intended use and results obtained to N Latex CRP. The N CRP Reagent, like the proposed product is intended to be used for the quantitative determination of C-reactive protein in human serum by particle enhanced nephelometry

The N Latex CRP mono Reagent differs from the N Latex CRP in that the N Latex CRP mono Reagent is calibrated using a lot independent standard, whereas the N CRP Reagent is calibrated using a lot dependent standard (included in the kit). Also, the N Latex CRP mono Reagent is a liquid reagent consisting of polystyrene particles coated with mouse monoclonal antibodies to CRP, where as the N CRP Reagent is a lyophilized reagent containing polystyrene particles which are coated with antibodies of the γ-fraction from a specific rabbit anti-human-CRP serum. Additionally, the N Latex CRP mono Reagent is designed to measure CRP concentrations within an overall range of approx. 0.175 - 1100 mg/l, whereas, the N Latex CRP measuring range is approx. 0.625 - 800 mg/l. A copy of the N Latex CRP Reagent package insert is included in this submission.

7. Proposed Device Performance Characteristics:

Correlation

Results of comparative studies using the N Latex CRP mono Reagent and the N Latex CRP test kit for 71 serum samples gave a correlation coefficient of 0.98 and a y-intersept of 1.43, and a slope of 0.95.

Precision

N Latex CRP mono Reagent was used to measure 3 different CRP concentrations (approx. 15, 25 and 60 mg/l) and yielded coefficients of variation of 4.0%, 2.3% and 4.4% for the intra-assay precision (n = 20).

Five CRP concentrations (approx. 10, 15, 25, 45 and 60 mg/l) were used to determine the inter-assay reproducibility (n = 10) and here the coefficients of variation ranged from 2.6% to 5.7%.