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.
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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%.
