N LATEX B2-MICROGLOBULIN REAGENT

K955596 · Behring Diagnostics, Inc. · JZG · Oct 3, 1996 · Immunology

Device Facts

• Record ID: K955596
• Device Name: N LATEX B2-MICROGLOBULIN REAGENT
• Applicant: Behring Diagnostics, Inc.
• Product Code: JZG · Immunology
• Decision Date: Oct 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

N Latex B2-Microglobulin Reagent is an in vitro diagnostic reagent for the quantitative determination of human B2-microglobulin in serum by means of particle-enhanced nephelometry. Measurement of B2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Device Story

In vitro diagnostic reagent for quantitative determination of B2-microglobulin in serum; used with Behring Nephelometer Systems. Principle: particle-enhanced nephelometry; polystyrene latex particles coated with anti-human B2-microglobulin antibodies agglutinate upon binding sample B2-microglobulin. Agglutination increases light scattering intensity; nephelometer measures scattered light; concentration determined via reference to known standards. Used in clinical laboratory settings by trained personnel. Output: quantitative B2-microglobulin concentration. Clinical utility: aids diagnosis of active rheumatoid arthritis and kidney disease.

Clinical Evidence

Method comparison study performed on 84 serum samples comparing N Latex B2-Microglobulin Reagent to a commercially available enzyme immunoassay. Results: correlation coefficient of 0.987, y-intercept of 0.215, and slope of 0.967. Precision studies: intra-assay CV 2.5-3.3% (n=20); inter-assay CV 2.1-3.0% (n=8). Assay range: 0.62 to 20 mg/l (1:100 dilution) or up to 80 mg/l (1:400 dilution).

Technological Characteristics

In vitro diagnostic reagent; polystyrene latex particles coated with specific antibodies to human B2-microglobulin. Detection principle: particle-enhanced nephelometry (light scattering). Energy source: nephelometer light source. Connectivity: used with Behring Nephelometer Systems. No software algorithm details provided.

Indications for Use

Indicated for the quantitative determination of human B2-microglobulin in serum to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Regulatory Classification

Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Predicate Devices

• Abbott IMx B2 Microglobulin

Submission Summary (Full Text)

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Ke 955594

Behring Diagnostic Inc
N Latex B2-Microglobulin Reagent
510(k) Notification

Attachment 1

OCT - 3 1996

# 510(k) Summary of Safety and Effectiveness for N Latex B2-Microglobulin Reagent

1. Manufactures Name, Address, Telephone, and contact person, date of preparation:

Manufacturer
Behringwerke AG
Postfach 1140
35001 Marburg
Germany

Distributor
Behring Diagnostics Inc.
151 University Avenue
Westwood, MA 02090
617-320-3000
Attn: Kathleen Dray-Lyons

Preparation date: July 16, 1996

2. Device Name/ Classification:

N Latex B2-Microglobulin Reagent: reagent for the quantitative determination of B2-Microglobulin
Classification Number: class II (866.5630)

3. Identification of the legally marketed device:

Abbott IMx B2 Microglobulin

4. Proposed Device Description:

The N Latex Microglobulin Reagent is a reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of B2-microglobulin in serum. Polystyrene latex particles coated with specific antibodies to human B2-microglobulin are agglutinated when mixed with samples containing B2-microglobulin. The intensity of the resulting scattered light measured by the nephelometer is dependent upon the B2-microglobulin content of the sample which is determined by reference to standards of known concentrations.

5. Proposed Device Intended Use:

N Latex B2-Microglobulin Reagent is an in vitro diagnostic reagent for the quantitative determination of human B2-microglobulin in serum by means of particle-enhanced nephelometry. Measurement of B2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

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{1}

Behring Diagnostic Inc
N Latex B2-Microglobulin Reagent
510(k) Notification

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

The B2-Microglobulin assay using the proposed product is substantially equivalent in intended use and results obtained to the Abbott IMx B2 Microglobulin. The Abbott IMx B2 Microglobulin like the proposed product, depends upon assaying standards of known B2-microglobulin content to convert the measured signal to concentrations. Both tests utilize specific antibody to B2-microglobulin for capture of the B2-microglobulin present in sample.

The N Latex B2-Microglobulin Reagent differs from the Abbott IMx B2 Microglobulin in that the Abbott IMx B2 Microglobulin assay is a sequential binding assay which consists of an antibody-antigen complex that is transferred to a glass fiber and measured using a fluorometer; while the N Latex B2-Microglobulin Reagent contains antibody that is affixed to a polystyrene particle which binds the B2-microglobulin in the patient sample. The polystyrene particles agglutinate, increasing the amount of light a given concentration of B2-microglobulin can scatter, effectively amplifying the signal when measured by a nephrolometer.

7. Proposed Device Performance Characteristics:

Assay range and sensitivity

The N Latex B2-Microglobulin Reagent is designed to measure B2-microglobulin concentrations within an assay range of approx. 0.62 to 20 mg/l for a sample dilution of 1:100. If a sample dilution of 1:400 is used the assay range is extended to approx. 80 mg/l.

The sensitivity is given by the lower limit of the reference curve and thus depends on the B2-microglobulin concentration of the standard.

Precision and reproducibility

Intra-assay precision was determined by assaying three B2-microglobulin concentrations (approx. 1.2, 1.5 and 6.0 mg/l) in replicates of twenty (20), the coefficient of variation ranged from 2.5 to 3.3 %.

Inter-assay precision was determined by assaying three B2-microglobulin concentrations (approx. 1.0, 1.4, and 5.8 mg/l) for a total of eight (8) replicates, the coefficient of variation ranged from 2.1 to 3.0%.

Method comparison (accuracy)

Results of comparative studies using the N Latex B2-Microglobulin Reagent and a commercially available enzyme immunoassay for 84 serum samples gave a correlation coefficient of 0.987, a y-intercept of 0.215, and a slope of 0.967.

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