IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT

K974564 · Beckman Instruments, Inc. · DEB · Feb 17, 1998 · Immunology

Device Facts

• Record ID: K974564
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DEB · Immunology
• Decision Date: Feb 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5620
• Device Class: Class 2

Intended Use

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

Device Story

The IMMAGE Immunochemistry System AMG Reagent is an in vitro diagnostic reagent used with the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure human alpha-macroglobulin concentrations in serum samples. The system uses goat-derived antibodies to react with the target protein; the resulting light scattering is measured to quantify the analyte. The device is intended for use in clinical laboratory settings by trained personnel. Results are provided to clinicians to assist in the diagnosis of blood-clotting or clot lysis disorders.

Clinical Evidence

Performance data includes method comparison, stability, and imprecision experiments. The studies demonstrate substantial equivalence to existing chemistry test systems. No specific clinical trial metrics (e.g., sensitivity/specificity) were provided in the summary; evidence is based on analytical performance validation.

Technological Characteristics

Reagent for rate nephelometry; utilizes goat-derived antibodies. Designed for use on the Beckman IMMAGE Immunochemistry System. The system uses automated liquid handling and optical detection. No specific materials or connectivity standards are detailed.

Indications for Use

Indicated for the quantitative determination of human alpha-macroglobulin in human serum to aid in the diagnosis of blood-clotting or clot lysis disorders.

Regulatory Classification

Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

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 Alpha₂-Macroglobulin (AMG) (K791340)

Submission Summary (Full Text)

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# BECKMAN

<974564

# Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Alpha-Macroglobulin (AMG) Reagent

FEB 1 7 1998

- 1.0 Submitted By:
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:

December 4, 1997

#### 3.0 Device Name(s):

# 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha-Macroglobulin (AMG) Reagent

#### Classification Name 3.2

Alpha-Macroglobulin immunological test system (21 CFR § 866.5620)

#### 4.0 Predicate Device(s):

| IMMAGE System<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|------------------------------------------------|----------------------------------------|------------------------------|------------------|
| IMMAGE System<br>Alpha₂-<br>Macroglobulin(AMG) | Beckman Alpha₂-<br>Macroglobulin (AMG) | Beckman Instruments,<br>Inc. | K791340 |

#### 5.0 Description:

The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.

#### 6.0 Intended Use:

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

Beckman Instruments, Inc.

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Beckman Instruments, Inc., Section 510(k) Notification Beckhan instruments, inc., System Alpha-Macroglobulin (AMG) 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>AMG Reagent | Nephelometric methodology | Same as<br>Beckman AMG reagent |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System<br>AMG Reagent | Buffer/Reagent volumes | IMMAGE System uses half of the<br>volumes than are utilized by the Array<br>System for AMG. |
| | Antibody concentration | IMMAGE AMG has a higher antibody<br>concentration than the Beckman<br>Alpha-Macroglobulin reagent |

#### 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 companson, stability, and imprecision experiments that relate results obtained on the IMMAGE System.

# Method Comparison Study Results IMMAGE Alpha2Macroglobulin (AMG) Reagent

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# Stability Study Results

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# Estimated Imprecision

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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Annie Hellie Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92822-8000

FEB 1 7 1998

Re: K974564 Trade Name: Immage Immunochemistry System Alpha(2)-Macroglobulin (AMG) Reagent Regulatory Class: II Product Code: DEB 82 December 04, 1997 Dated: December 05, 1997 Received:

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, 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 Regulations, 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 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 requlations.

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Paqe 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 Butman

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):

page ⊥ of ⊥

Device Name: IMMAGE™ Immunochemistry System Alphaz-Macroglobulin (AMG) Reagent

K974564

Indications for Use:

Intended Use:

The IMMAGE Immunochemistry System Alpha~Macroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha~ macroglobulin by rate nephelometry.

Clinical Significance:

. . .

1

Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

Kittie E. Madson

(Division Sign-Om)
Division of Clinical Laboratory Devices
510(k) Number
K974564

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (per 21 CFR 801.109)

OR

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