IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT

K973813 · Beckman Instruments, Inc. · JZG · Nov 20, 1997 · Immunology

Device Facts

• Record ID: K973813
• Device Name: IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: JZG · Immunology
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System B2M Reagent is an in vitro diagnostic reagent used for the quantitative measurement of beta-2-microglobulin in human serum. The device utilizes rate nephelometry to determine concentration levels. It is designed for use on the Beckman IMMAGE Immunochemistry System, operated by laboratory professionals in a clinical setting. The system processes serum samples, and the resulting concentration data is used by clinicians to aid in patient assessment. The reagent utilizes goat-derived antibodies to detect the target protein. The system provides automated quantitative results, which assist healthcare providers in clinical decision-making regarding patient health status.

Clinical Evidence

Bench testing only. Performance was validated through method comparison, stability, and imprecision studies. Imprecision was evaluated across three levels (0.34, 1.65, 3.43 mg/dL) with N=80 per level, yielding %C.V. values of 8.5%, 2.7%, and 2.9% respectively. Shelf-life is 24 months, with 14-day open container and calibration stability.

Technological Characteristics

Rate nephelometry; goat-derived antibodies; reagent/buffer system optimized for IMMAGE Immunochemistry System; automated quantitative analysis; standalone clinical chemistry analyzer platform.

Indications for Use

Indicated for the quantitative determination of human beta-2-microglobulin in serum samples using rate nephelometry on the IMMAGE Immunochemistry System.

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

• Array Systems Beta-2-Microglobulin(B2M) (K940353)

Submission Summary (Full Text)

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# BECKMAN

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Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent

NOV 20 1997

#### Submitted By: 1.0

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

October 6, 1997

#### 3.0 Device Name(s):

# 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent

#### 3.2 Classification Name

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

#### 4.0 Predicate Device(s):

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

#### 5.0 Description:

The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.

#### 6.0 Intended Use:

The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.

Beckman Instruments, Inc.

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2017 11:22 PM IST 11:20 PM IST 1

Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent Summary of Safety & Effectiveness

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

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

| Reagent | Aspect/Characteristic | Comments |
|------------------------------|---------------------------|----------------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| IMMAGE System<br>B2M Reagent | Analytic Range | Same as Array System Beta-2-<br>Microglobulin reagent |
| | Off-line sample dilution | |
| | Nephelometric methodology | |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System<br>B2M Reagent | Buffer/Reagent volumes | IMMAGE System uses half of the<br>volumes than are utilized by the Array<br>System for B2M. |
| | Coreagent concentration | IMMAGE B2M has a higher coreagent<br>concentration than the Array Beta-2-<br>Microglobulin reagent |

#### 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 companson, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

# Method Comparison Study Results

## IMMAGE Beta-2-Microglobulin (B2M) Reagent

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|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |

### Stability Study Results

| Reagent | Product Claim |
|------------|----------------------------------------------------------------------------------------|
| IMMAGE B2M | 24 month shelf-life<br>14 day open container stability<br>14 day calibration stability |

### Estimated Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.34 | 0.029 | 8.5 | 80 |
| Level 2 | 1.65 | 0.045 | 2.7 | 80 |
| Level 3 | 3.43 | 0.099 | 2.9 | 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

NOV 20 1997

Re: K973813 IMMAGE™ Immunochemistry System Beta-2-Microglobulin Trade Name: (B2M) Reagent Regulatory Class: II Product Code: JZG Dated: October 6, 1997 Received: October 7, 1997

Dear Ms. Hellie:

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 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, labelinq, 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 requirement, 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 obligation 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 legally 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known): K973813

Device Name: IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent

Indications for Use:

The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when THE IMMAGE Inimanoonemisay Oyenni MMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2microglobulin in serum by rate nephelometry.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------------------------------------------------------------|--|--|
| | | |
| (Division Sign-Off)<br>Division of Clinical Laboratory Devices<br>510(k) Number ____________________________ | | |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-the-Counter Use _________ |
|----------------------|-----------------------------------------|----|--------------------------------|
| (per 21 CFR 801.109) | | | Optional Format 1-2-96 |