BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR

K993549 · Beckman Coulter, Inc. · CFN · Feb 1, 2000 · Immunology

Device Facts

• Record ID: K993549
• Device Name: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
• Applicant: Beckman Coulter, Inc.
• Product Code: CFN · Immunology
• Decision Date: Feb 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGMAC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin A in serum and cerebrospinal fluid by rate nephelometry.

Device Story

Device consists of IGALC reagent and CSF protein calibrator for use on IMMAGE Immunochemistry Systems. System utilizes rate nephelometry to measure light scatter from antigen-antibody complexes formed between goat anti-human IgA and IgA in patient serum or CSF samples. Operated by laboratory personnel in clinical settings. Output is quantitative IgA concentration (mg/L). Clinicians use results to assess blood-CSF barrier permeability and intrathecal immunoglobulin synthesis, aiding diagnosis of CNS conditions like meningitis, encephalitis, and tumors. System automates sample processing and measurement, providing objective data for clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison studies (N=50 per sample type) showed high correlation with predicate devices (r=0.984 for serum, r=0.991 for CSF). Imprecision studies (N=80 per level) demonstrated total CVs ranging from 3.1% to 4.5% across serum and CSF samples, supporting analytical performance claims.

Technological Characteristics

Rate nephelometry system; goat anti-human IgA antibody; liquid stable reagent; human urine-based calibrator with azide preservative; reaction temperature controlled at 37°C; automated clinical chemistry analyzer platform.

Indications for Use

Indicated for quantitative determination of human immunoglobulin A in serum and cerebrospinal fluid to detect increased blood-CSF barrier permeability and intrathecal immunoglobulin synthesis. Used in diagnosis of CNS diseases including brain tumor, intracerebral hemorrhage, meningitis, encephalitis, and bacterial infections.

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

• IMMAGE Immunochemistry System Immunoglobulin A (IGA) Reagent (K963868)
• N Latex IgA Reagents (K952309)

Submission Summary (Full Text)

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K99 3549

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. On the left is a circular graphic with a stylized design that looks like two leaves or waves. To the right of the graphic are the words "BECKMAN" on the top line and "COULTER" on the bottom line, with the words stacked on top of each other.

Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) Reagent Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL)

#### 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:

01 October 1999

#### 3.0 Device Name(s):

#### Proprietary Names 3.1

Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) Reagent Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL)

#### 3.2 Classification Name

Method, Nephelometric, Immunoglobulins (G, A, M) (21 CFR §866.5510)

#### 4.0 Predicate Device(s):

| IMMAGE System | Serum Predicate | Manufacturer | Docket Number |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------|---------------|
| IMMAGE System Low<br>Concentration<br>Immunoglobulin A (IGALC)<br>Reagent | IMMAGE<br>Immunochemistry<br>System<br>Immunoglobulin A<br>(IGA) Reagent | Beckman<br>Instruments,<br>Inc. | K963868 |
| Cerebrospinal Fluid Protein<br>Calibrator | | | |
| | CSF Predicate | Manufacturer | Docket Number |
| | N Latex IgA Reagents | Behring<br>Diagnostics,<br>Inc* | K952309 |

*Westwood, MA 02090

#### 5.0 Description:

The IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin A in serum and cerebrospinal fluid.

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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#### 6.0 Intended Use:

The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGMAC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin A in serum and cerebrospinal fluid by rate nephelometry.

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

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

# SIMILARITIES to the SERUM PREDICATE

| SIMILARITIES to the SERUM PREDICATE | | |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| IMMAGE System | Aspect/Characteristic | Comments |
| IMMAGE System IGALC Reagent | Intended use<br>Rate nephelometry method<br>Antibody is goat antihuman IgA | Same as<br>Predicate<br>device |
| Cerebrospinal Fluid Protein Calibrator | Single level calibrator | |
| SIMILARITIES to the CSF PREDICATE | | |
| IMMAGE System | Aspect/Characteristic | Comments |
| IMMAGE System IGALC<br>Reagent | Intended use and serum and CSF are<br>acceptable sample types<br>Reagent storage at 2°C to 8°C | Same as predicate<br>device |
| IMMAGE Cerebrospinal Fluid<br>Protein Calibrator | Protein is of human serum origin<br>Contains azide as a preservative | |
| DIFFERENCES from the SERUM PREDICATE | | |
| IMMAGE System | Aspect/Characteristic | Comments |
| IMMAGE System<br>IGALC Reagent | Serum or CSF as sample type | Predicate cleared for serum only |
| IMMAGE<br>Cerebrospinal Fluid<br>Protein Calibrator | CSF CAL Cerebrospinal Fluid<br>Calibrator is a single level, human<br>urine base, azide preserved liquid | Predicate calibrator is a single<br>level, human serum based, azide<br>preserved liquid |
| DIFFERENCES from the CSF PREDICATE | | |
| IMMAGE System | Aspect/Characteristic | Comments |
| IMMAGE System IGALC<br>Reagent | IMMAGE System IGALC reaction<br>is at a controlled 37°C<br>Antibody source for IMMAGE<br>IGALC is goat<br>IMMAGE Reagent is liquid stable | Behring N Latex IgA reaction is at<br>room temperature<br>Antiserum source for Behring N<br>Latex Reagent is rabbit<br>Behring Reagent is lyophilized |
| IMMAGE Cerebrospinal | IMMAGE Cerebrospinal Fluid | Behring N IgA Standard is |

## 8.0

Summary of Performance Data:

Fluid Protein Calibrator

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.

Ivophilized

Beckman Coulter, Inc. IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent Filename: igalcSSE.doc

Calibrator is liquid

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| | IMMAGE IGALC Reagent<br>Serum<br>IMMAGE IGA | CSF<br>Behring N Latex IgA |
|-------------------------|---------------------------------------------|----------------------------|
| N | 50 | 50 |
| Slope | 0.973 | 1.056 |
| Intercept | 91.02 | 0.56 |
| Mean (IGALC) mg/L | 2035 | 6.59 |
| Mean (predicate) mg/L | 1999 | 5.72 |
| Correlation Coefficient | 0.984 | 0.991 |

Estimated IMMAGE System IGALC Reagent Imprecision (Serum)

| PRECISION | SAMPLE | N | MEAN (mg/L) | SD (mg/L) | % CV |
|------------|--------|----|-------------|-----------|------|
| Within-Run | Low | 80 | 334 | 12.7 | 3.8 |
| | Mid | 80 | 1818 | 60.3 | 3.3 |
| | High | 80 | 2922 | 89.7 | 3.1 |
| Total | Low | 80 | 334 | 15.2 | 4.5 |
| | Mid | 80 | 1818 | 64.7 | 3.6 |
| | High | 80 | 2922 | 103.3 | 3.5 |

Estimated IMMAGE System IGALC Reagent Imprecision (CSF)

| PRECISION | SAMPLE | N | MEAN<br>(mg/L) | SD<br>(mg/L) | % CV |
|------------|--------|----|----------------|--------------|------|
| Within-Run | Low | 80 | 5.06 | 0.188 | 3.7 |
| | Mid | 80 | 29.3 | 0.72 | 2.5 |
| | High | 80 | 59.8 | 2.29 | 3.8 |
| Total | Low | 80 | 5.06 | 0.208 | 4.1 |
| | Mid | 80 | 29.3 | 0.79 | 2.7 |
| | High | 80 | 59.8 | 2.70 | 4.5 |

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.

Beckman Coulter, Inc. IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent Filename: igalcSSE.doc

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### FEB 1 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard T. Ross Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92622-8000

Re: K993549

> Trade Name: IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) Reagent Beckman Coulter " Cerebrospinal Fluid Protein Calibrator (CSF CAL) Regulatory Class: II Product Code: CFN Dated: December 20, 1999 Received: December 21, 1999

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 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 regulations.

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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" (21CFR 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 Autman

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 of

99.354 510(k) Number (if known): Not yet assic

Device Name:

IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) Reagent Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL)

Indications for Use:

The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin A in serum and cerebrospinal fluid by rate nephelometry.

Clinical Significance:

The concentration ratio of immunoglobulins in CSF and serum detects increased permeability of the blood-CSF barrier and intrathecal synthesis of immunoglobulins.

The permeability of the blood-CSF barrier to plasma increases due to brain tumor, intracerebral hemormage, meningitis, encephalitis, and bacterial infections. The intrathecal synthesis of immunoglobulins is important in the diagnosis of diseases of the Central Nervous Systems (CNS).

> Method, Nephelometric, Immunoglobulins (G, A, M) (21 CFR §866.5510)

(b) Classification. Class I I.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | 4995549 |
|---------------|---------|
|---------------|---------|

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

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