IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT

K983895 · Beckman Coulter, Inc. · JZG · Nov 25, 1998 · Immunology

Device Facts

• Record ID: K983895
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: JZG · Immunology
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin in serum or plasma by rate nephelometry.

Device Story

IMMAGE® Immunochemistry System B2MX Reagent performs quantitative determination of beta-2-microglobulin in serum or plasma; utilizes rate nephelometry; requires IMMAGE® Immunochemistry System and Calibrator 2. System automates sample dilution; uses latex particle-bound rabbit polyclonal antibodies. Operated by laboratory personnel in clinical settings. Output provides concentration values used by physicians to assess glomerular filtration rate (GFR) and manage rheumatoid arthritis or renal disease. Benefits include automated processing compared to manual predicate methods.

Clinical Evidence

Bench testing only. Method comparison study (n=111) comparing IMMAGE B2MX to Array 360 predicate yielded slope 0.979, intercept -0.017 mg/dL, and r=0.996. Imprecision studies (n=80 per level) showed within-run %CV of 1.9-10.0% and total imprecision %CV of 2.2-10.0% across three concentration levels (0.10 to 3.19 mg/dL).

Technological Characteristics

Rate nephelometry; latex particle-enhanced immunoassay. Reagent contains rabbit polyclonal antibodies bound to latex particles. System features automated on-line sample dilution. Reaction temperature 37°C. Designed for use on IMMAGE® Immunochemistry Systems.

Indications for Use

Indicated for quantitative determination of human beta-2-microglobulin in serum or plasma to assist in diagnosis and management of patients with active rheumatoid arthritis and renal 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

• Beckman Array® Beta-2-Microglobulin (B2M) (K940353)

Reference Devices

• Array 360 Beta-2-Microglobulin

Submission Summary (Full Text)

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# Summary of Safety & Effectiveness

Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent

### 1.0 Submitted By:

Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea. California 92822-8000 Telephone: [phone] FAX: [phone]

### 2.0 Date Submitted:

02 November 1998

# 3.0 Device Name(s):

### Proprietary Names 3.1

IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent

### 3.2 Classification Name

(21 CFR §866.5630) Beta-2-Microglobulin immunological test system

### 4.0 Predicate Device(s):

| IMMAGE Reagent | Predicate | Manufacturer | Docket<br>Number |
|-------------------------------------------------|-----------------------------------------------|------------------------------|------------------|
| IMMAGE System<br>Beta-2-Microglobulin<br>(B2MX) | Beckman Array® Beta-<br>2-Microglobulin (B2M) | Beckman<br>Instruments, Inc. | K940353 |

# 5.0 Description:

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.

# 6.0 Intended Use:

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin in serum or plasma by rate nephelometry.

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#### 7.0 Comparison to Predicate(s):

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

| IMMAGE<br>System | Aspect/Characteristic | Comments |
|------------------|--------------------------------------------|----------------------------------------|
| IMMAGE<br>System | Intended use | Same as Array Beta-2-<br>Microglobulin |
| B2MX<br>Reagent | Reaction temperature of 37° C | |
| | Detection methodology of rate nephelometry | |

# SIMILARITIES to the PREDICATE

# DIFFERENCES from the PREDICATE

| IMMAGE<br>System | Aspect/Characteristic | Comments |
|------------------|---------------------------------|---------------------------------------------------------------------------------|
| IMMAGE<br>System | Sample dilution | IMMAGE has on line sample dilution.<br>Array requires off line sample dilution. |
| B2MX<br>Reagent | Antibody source | IMMAGE is rabbit (polyclonal). Array is<br>goat (polyclonal). |
| Reagent | Antibody reagent<br>composition | IMMAGE is latex particle bound antibody.<br>Array is soluble antibody. |

#### Summary of Performance Data: 8.0

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 and imprecision experiments.

# Method Comparison Study Results

# IMMAGE® System Beta-2-Microglobulin (B2MX) Reagent

| Analyte | Sample<br>Type | Slope | Intercept<br>(mg/dL) | r | n | Predicate Method |
|---------------------------|----------------|-------|----------------------|-------|-----|---------------------------------------|
| IMMAGE<br>B2MX<br>Reagent | serum | 0.979 | -0.017 | 0.996 | 111 | Array 360<br>Beta-2-<br>Microglobulin |

# IMMAGE® System Beta-2-Microglobulin (B2MX) Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---------|--------------|------------------------|-------|----|
| | | Within-Run Imprecision | | |
| Level 1 | 0.10 | 0.010 | 10.0 | 80 |
| Level 2 | 1.84 | 0.042 | 2.3 | 80 |
| Level 3 | 3.19 | 0.062 | 1.9 | 80 |
| | | Total Imprecision | | |
| Level 1 | 0.10 | 0.010 | 10.0 | 80 |
| Level 2 | 1.84 | 0.048 | 2.6 | 80 |
| Level 3 | 3.19 | 0.069 | 2.2 | 80 |

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.

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Public Health Service

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000

Re: K983895 IMMAGE® Immunochemistry System Beta-2 Microglobulin Trade Name: Reagent Regulatory Class: II Product Code: JZG November 2, 1998 Dated: Received: November 3, 1998

Dear Mr. Ross:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of 1

K983895 510(k) Number (if known): Not vet assigned-

Device Name:

IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent

Indications for Use:

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.

Clinical Significance:

An increase in the concentration of serum beta-2-microglobulin can result from an overproduction of the protein by nucleated cells and/or decreased clearance by the kidneys. Under normal conditions, beta-2-microglobulin passes readily through the glomerular membrane. Levels of beta-2microglobulin in serum, therefore, are inversely proportional to glomerular filtration rate (GFR). Measurement of Beta-2-Microglobulin in serum or plasma assists in the diagnosis and management of patients with active rheumatoid arthritis and renal disease.

(21 CFR §866.5630) Beta-2-Microglobulin immunological test system

(b) Classification. Class II.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE).

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | K983895 |
| 510(k) Number | |

| Prescription Use (per 21 CFR 801.109) | <div> <img alt="Tick" src="tick.png"/> </div> |
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OR

| Over-the-Counter Use | |
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| Optional Format 1-2-96 | |