SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT

K965108 · Beckman Instruments, Inc. · DEW · Mar 6, 1997 · Immunology

Device Facts

• Record ID: K965108
• Device Name: SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DEW · Immunology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

Device Story

Reagents for quantitative determination of human Ig-G, Ig-A, and Ig-M in serum or plasma; used on SYNCHRON LX clinical chemistry analyzers. Principle: antigen-antibody complex formation measured via turbidimetry at 37°C and 340 nm. High antigen concentration detection prevents false-in-range reporting. Reagents stored in polystyrene cartridges onboard instrument. Healthcare providers use results for clinical assessment of immunoglobulin levels. Benefits: automated, standardized quantification of immunoglobulins for diagnostic support.

Clinical Evidence

Bench testing only. Method comparison study (n=72-82) against predicate methods showed high correlation (r=0.9914 to 0.9970). Within-run imprecision (%CV) ranged from 1.3% to 3.9% across two levels for all three analytes. Stability data supports 24-month shelf-life, 14-day calibration stability, and 60-day on-board stability.

Technological Characteristics

Turbidimetric assay; 37°C reaction temperature; 340 nm endpoint detection. Reagents packaged in polystyrene cartridges. Onboard refrigerated storage. Uses tris buffer for sample dilution. Single-point calibration update.

Indications for Use

Indicated for quantitative determination of human immunoglobulin G, A, and M in serum or plasma using clinical chemistry analyzers.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• Beckman Immunoglobulin G (IGG) Reagent (K771603)
• Beckman Immunoglobulin A (IGA) Reagent (K771603)
• Beckman Immunoglobulin M (IGM) Reagent (K771603)

Submission Summary (Full Text)

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness
K965108
MAR - 6 1997

Summary of Safety & Effectiveness

SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, & Ig-M) Reagents

## 1.0 Submitted By:

Kathleen M. Jaker
Senior Applications Chemist
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-117
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

## 2.0 Date Submitted:

18 December 1996

## 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON LX™ Systems Immunoglobulin G (Ig-G) Reagent
SYNCHRON LX™ Systems Immunoglobulin A (Ig-A) Reagent
SYNCHRON LX™ Systems Immunoglobulin M (Ig-M) Reagent

### 3.2 Classification Names

Immunoglobulin G Test System (21 CFR §866.5510)
Immunoglobulin A Test System (21 CFR §866.5510)
Immunoglobulin M Test System (21 CFR §866.5510)

## 4.0 Predicate Device(s):

| SYNCHRON LX Reagents | Predicate | Predicate Company | Docket Number |
| --- | --- | --- | --- |
| Immunoglobulin G (Ig-G) Reagent | Beckman Immunoglobulin G (IGG) Reagent | Beckman Instruments, Inc. | K771603 |
| Immunoglobulin A (Ig-A) Reagent | Beckman Immunoglobulin A (IGA) Reagent | Beckman Instruments, Inc. | K771603 |
| Immunoglobulin M (Ig-M) Reagent | Beckman Immunoglobulin M (IGM) Reagent | Beckman Instruments, Inc. | K771603 |

file: ig510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness

# 5.0 Description:

The SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

# 6.0 Intended Use:

The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

# 7.0 Comparison to Predicate(s):

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

SIMILARITIES to the PREDICATE

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SYNCHRON LX Systems Immunoglobulin (Ig-G, Ig-A, & Ig-M) Reagents | Intended Use | Same as Beckman Immunoglobulin reagents; quantitative determination of human immunoglobulins |
| | Chemical Reaction | Same principle as the Immunoglobulin Beckman Reagents; formation of antigen-antibody complex |
| | Antibody | Same source, antibody, processing, and buffer as Beckman Immunoglobulin reagents |
| | Range Expansion | Same as the Beckman Immunochemistry (ARRAY) System which expands usable range with alternate sample dilution ratios |
| | Calibration | Same as the Beckman Immunoglobulin reagents; single point update of manufacturer-determined calibration curve. |

file: ig510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness

DIFFERENCES from the PREDICATE

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SYNCHRON LX Systems Immunoglobulin (Ig-G, Ig-A, & Ig-M) Reagents | Methodology | The SYNCHRON LX reads turbidimetrically and the ARRAY Systems read nephelometrically |
| | Measurement Method | The SYNCHRON LX runs the reaction at 37°C and reads an endpoint at 340 nm; the ARRAY Systems run at 26.5°C and read at a peak rate at 450-550 nm |
| | Antigen Excess Checking | The SYNCHRON LX Reagents are designed so that high antigen concentration will not report in range; the ARRAY Systems add extra antibody to observe for additional activity. |
| | Sample Diluent | The SYNCHRON LX uses a tris buffer for sample dilution; the ARRAY Systems use a phosphate buffered diluent. |
| | Reagent Storage | The SYNCHRON LX reagents are stored refrigerated onboard the instrument; the ARRAY Systems reagents are stored at room temperature onboard the instrument/ refrigerated when not in use. |
| | Packaging | The SYNCHRON LX reagents are packaged in polystyrene cartridges; the ARRAY Systems reagents are in glass bottles. |

file: ig510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness

## 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 Beckman Immunoglobulin Reagents (IGG, IGA, IGM) to the SYNCHRON LX Systems Immunoglobulin Reagents (Ig-G, Ig-A, Ig-M).

### Method Comparison Study Results
#### SYNCHRON LX Systems Ig-G, Ig-A, & Ig-M Reagents

| Reagent | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- |
| SYNCHRON LX Immunoglobulin G Reagent (Ig-G) | 0.928 | 72.7 | 0.9970 | 82 | Beckman's Immunoglobulin IGG Reagent |
| SYNCHRON LX Immunoglobulin A Reagent (Ig-A) | 0.924 | 0.68 | 0.9962 | 78 | Beckman's Immunoglobulin IGA Reagent |
| SYNCHRON LX Immunoglobulin M Reagent (Ig-M) | 1.051 | -17.19 | 0.9914 | 72 | Beckman's Immunoglobulin IGM Reagent |

### Estimated Within-Run Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin G (Ig-G) | | | | |
| Level 1 | 527 | 6.9 | 1.3 | 80 |
| Level 2 | 1103 | 16.1 | 1.5 | 80 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin A (Ig-A) | | | | |
| Level 1 | 109 | 1.8 | 1.7 | 80 |
| Level 2 | 242 | 4.0 | 1.7 | 80 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin M (Ig-M) Reagent | | | | |
| Level 1 | 46.6 | 1.8 | 3.9 | 80 |
| Level 2 | 103.5 | 2.3 | 2.2 | 80 |

file: ig510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness

## Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| SYNCHRON LX Systems
Immunoglobulin G, A, & M Reagents | 24 month shelf-life
14 day calibration stability
60 days on-board stability |

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: ig510k.sse