N ANTISERUM TO C1 INHIBITOR

K960257 · Behring Diagnostics, Inc. · DBA · Aug 1, 1996 · Immunology

Device Facts

• Record ID: K960257
• Device Name: N ANTISERUM TO C1 INHIBITOR
• Applicant: Behring Diagnostics, Inc.
• Product Code: DBA · Immunology
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5250
• Device Class: Class 2

Intended Use

In vitro diagnostic reagent for the quantitative determination of C1 Inhibitor (C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Device Story

In vitro diagnostic reagent; quantitative determination of C1 Inhibitor in human plasma/serum. Principle: immunochemical reaction; C1 Inhibitor forms immune complexes with specific antibodies; complexes scatter light beam; intensity proportional to protein concentration. Used with Behring Nephelometers. Results evaluated via comparison with 5-point standard curve. Aids clinicians in diagnosing hereditary angioneurotic edema and lymphoma-associated angioedema.

Clinical Evidence

Bench testing only. Correlation study (n=50 serum samples) vs. BIND A RID™ C1: r=0.973, y-intercept=3.74, slope=0.85. Precision: Inter-assay (n=10, 5 days) 0.89-7.73 %CV; Intra-assay (n=30) 1.31-2.89 %CV.

Technological Characteristics

Immunochemical reagent for nephelometric analysis. Utilizes specific antibodies to C1 inhibitor. Quantitative measurement via light scattering intensity. Compatible with Behring Nephelometers. 5-point standard curve calibration.

Indications for Use

Indicated for quantitative determination of C1 Inhibitor in human plasma and serum to aid in diagnosis of hereditary angioneurotic edema and angioedema associated with lymphoma.

Regulatory Classification

Identification

A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Predicate Devices

• BIND A RID™ C1

Submission Summary (Full Text)

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K960257

AUG - 1 1996

attachment 1

510(k) Summary of Safety and Effectiveness for N Antiserum to C1 Inhibitor

1. Manufacturer Name, Address, 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: June 27, 1996

2. Device Name/Classification:

Reagents for use in the determination of Complement C1 Inhibitor /Class II (866.5250)

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

The Binding Site Limited BIND A RID™ C1

4. Proposed Device Description:

In vitro diagnostic reagent for the quantitative determination of C1 Inhibitor (C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

5. Proposed Device Intended Use:

In vitro diagnostic reagent for the quantitative determination of C1 Inhibitor (C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema

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(increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

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

The C1 Inhibitor assay using the proposed product is substantially equivalent in intended use and results obtained to the BIND A RID™ C1 assay. The N Antiserum to C1 inhibitor like the proposed product, depends upon assaying standards of known C1 content to convert the measured value to concentration. Both tests utilize specific antibody to C1 inhibitor for capture of the C1 present in sample.

N Antiserum to C1 Inhibitor differs from the BIND A RID™ C1 test in that the BIND A RID™ C1 test measures the concentration of C1 Inhibitor in an unknown sample by measuring the ring diameter and manually reading off a calibration curve, while the N Antiserum to C1 Inhibitor measures C1 inhibitor concentration using a nephelometer. Also, the N Antiserum to C1 Inhibitor assay is based on a 5 point standard curve, whereas the BIND A RID™ C1 is based on a 3 point standard curve. Additionally, the BIND A RID™ C1 is intended for use with serum samples only, while the N Antiserum C1 is intended for use with both serum and plasma. These differences do not affect the safety and effectiveness as demonstrated by excellent correlation to the BIND A RID™ C1 test across the assay range.

## 7. Proposed Device Performance characteristics:

### Correlation:

Results of comparative studies using the N Antiserum to C1 Inhibitor and the BIND A RID™ C1 for 50 serum samples gave a correlation coefficient of 0.973 and a y-intercept of 3.74 and a slope of 0.85.

### Precision:

Inter-assay precision studies were run over a 5 day period, twice per day, to total n=10 precision ranged from 0.89-7.73 %CV. Intra-assay precision was calculated from n=30 precision ranges from 1.31 - 2.89 %CV.

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