BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER

K130122 · Beckman Coulter, Inc. · CFN · Jan 7, 2014 · Immunology

Device Facts

• Record ID: K130122
• Device Name: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
• Applicant: Beckman Coulter, Inc.
• Product Code: CFN · Immunology
• Decision Date: Jan 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of immunoglobulin M in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

Device Story

IMMAGE Immunochemistry System uses rate nephelometry to measure human IgM concentration in serum and CSF. System automatically dilutes and delivers samples and reagents to reaction cuvettes. Particle-bound anti-IgM antibodies bind to IgM, forming insoluble complexes that increase light scatter. 670 nm laser light source; detector at 90° angle measures scatter intensity increase. System calculates rate of change of scatter signal, which is directly proportional to IgM concentration. Used in clinical laboratories by trained personnel. Output provides quantitative IgM levels to assist clinicians in diagnosing CNS conditions related to blood-CSF barrier permeability and intrathecal synthesis.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 per sample pool); total %CV ranged 2.85-15.64% for CSF and 2.85-10.84% for serum. Linearity demonstrated per CLSI EP06-A (r² ≥ 0.997). Method comparison (n=80) against predicate showed high correlation (R² ≥ 0.994 for CSF, R² ≥ 0.995 for serum). LoB, LoD, and LoQ established per CLSI EP17-A.

Technological Characteristics

Rate nephelometry; 670 nm laser light source; 90-degree detector angle. Automated random-access analyzer. Reagent formulation includes particle-bound anti-IgM antibodies. Traceable to ERM-DA-470(k)-IFCC standard. Analytical range: 0.15-10 mg/L (CSF) and 32.4-2160 mg/L (Serum).

Indications for Use

Indicated for quantitative determination of Immunoglobulin M (IgM) in human serum or cerebrospinal fluid (CSF) for clinical laboratory use. Prescription use only.

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 Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent (K993547)
• Beckman Coulter Cerebrospinal Fluid Protein Calibrator (CSF CAL) (K993547)

Submission Summary (Full Text)

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# 510(k) SUMMARY

#### 1.0 Submitted By:

Amanda Brown Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Boulevard M/S E1.2902 Brea, California 92821 Telephone: [phone] Email: [e-mail]

### 2.0 Date Submitted:

December 19, 2013

### 3.0 Device Name(s):

### 3.1 Proprietary Names

IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent IMMAGE® Immunochemistry System Cerebrospinal Fluid Protein Calibrator (CSF CAL)

#### 3.2 Classification Name

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

Calibrator, multi-analyte mixture (21 CFR § 862.1150) [JIX]

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------|------------------|
| Beckman Coulter<br>IMMAGE®<br>Immunochemistry<br>System Low<br>Concentration<br>Immunoglobulin M<br>(IGMLC) Reagent | Beckman Coulter<br>IMMAGE®<br>Immunochemistry System<br>Low Concentration<br>Immunoglobulin M<br>(IGMLC) Reagent | Beckman Coulter,<br>Inc. | K993547 |
| Beckman Coulter<br>Cerebrospinal Fluid<br>Protein Calibrator (CSF<br>CAL) | Beckman Coulter<br>Cerebrospinal Fluid<br>Protein Calibrator (CSF<br>CAL) | | |

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#### 5.0 Description:

The IMMAGE System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator is intended for the quantitative determination of human Immunoglobulin M in serum and cerebrospinal fluid (CSF) by rate nephelometry.

The IMMAGE Immunochemistry System (cleared under K962294) is a high throughput, random access analyzer that uses rate nephelometry methodology to measure human immunoglobulin M concentration in serum and CSF samples. The IMMAGE Immunochemistry System automatically dilutes and delivers sample to the reaction cuvette along with reagents and other reaction constituents.

During the reaction, particle bound anti-IgM antibody binds to IgM molecules in the sample via an antigen-antibody reaction. This results in the formation of insoluble complexes causing an increase in light scatter. The rate of increase in light scattered from the particles suspended in solution is directly proportional to the concentration of immunoglobulin M in the sample.

The rate nephelometer measures the increase in the intensity of light scattered by particles suspended in a cuvette. The light source for the rate nephelometer is a 670 nm wavelength laser. The detector is placed at a 90° angle from the incident beam to measure light increase. At the end of the reaction, the system mathematically calculates the rate of change of the scatter signal.

#### 6.0 Intended Use:

IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of immunoglobulin M in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

# Clinical Siqnificance:

The concentration ratio of immunoglobulins in CSF and serum detects increased permeability of the blood-CSF barrier and intrathecal synthesis of immunoqlobulins. 1.2

The permeability of the blood-CSF barrier to plasma increases due to brain tumor, intracerebral hemorrhage, meningitis, encephalitis, and bacterial infections. The intrathecal synthesis of immunoglobulins is important in the diagnosis of diseases of the Central Nervous System (CNS) 3

- European Neurology 1996; 36; 201-205 1.
- ﻨ Journal of the Neurological Sciences 184 (2001) 101-122
- Burtis, C. A., Ashwood, E. R., Tietz, Texbook of Clinical Chemistry, 3rd Edition, W. B. 3. Saunders, Philadelphia, PA (1999). '

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### 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary. Each modification was evaluated against the criteria for a Special 510(k) to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

| Similarities | | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| IMMAGE<br>IGMLC<br>Reagent | Intended Use<br>Reagent formulation<br>Calibrator formulation<br>Technology<br>Methodology<br>Kit configuration<br>Specimen types<br>Stability<br>Reference Interval<br>Precision specification<br>Interferences | | |
| Differences | | | |
| IMMAGE<br>IGMLC<br>Reagent | Reagent curve fit optimization<br>Sensitivity | Additional standards added to the low end of the curve.<br>Current:<br>CSF: 0.3 mg/L<br>Serum: 64.8 mg/L | New:<br>0.15 mg/L<br>32.4 mg/L |
| | Calibrator<br>traceability | Improved traceability to the international standard,<br>ERM-DA-470(k)-IFCC. | |
| | Analytical<br>Range | Current:<br>CSF 0.3-10 mg/L<br>Serum 64.8-2160 mg/L | New:<br>0.15 - 10 mg/L<br>32.4 - 2160 mg/L |
| | Imprecision<br>Value | Included CSF typical imprecision with sample<br>mean concentration between 0.15-0.30 mg/L and<br>updated low end serum sample with mean<br>concentration between 32.4-64.8 mg/L | |
| | Equivalency | Current:<br>CSF: Concordance to IFE method (obsolete)<br>Serum: Comparison to IGM assay<br>New:<br>CSF: Comparison to current assay<br>Serum: Comparison to current assay | |

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### 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, linearity, and imprecision, and sensitivity experiments.

| Sample Type | Acceptance<br>Criteria | N | R | Slope | Intercept | Result |
|-------------|---------------------------------------------------------------|----|-------|-------|-----------|--------|
| CSF | Slope: 1.0 +/- 0.10<br>Intercept: < 0.075<br>mg/L<br>R: ≥0.95 | 80 | 0.997 | 0.963 | -0.133 | Pass |
| Serum | Slope: 1.0 +/- 0.10<br>Intercept: N/A<br>R: ≥ 0.95 | 80 | 0.997 | 1.048 | 5.70 | Pass |

# Method Comparison Study Results

| Precision Study Results | | | | | | |
|-------------------------|----|----------------|-------------------------------------|--------------------------------------|--------------------------------------|--------------------------------|
| Sample | N | Mean<br>(mg/L) | Within-Run<br>Precision<br>SD / %CV | Between Run<br>Precision<br>SD / %CV | Between Day<br>Precision<br>SD / %CV | Total<br>Precision<br>SD / %CV |
| CSF1 | 80 | 0.196 | 0.03 mg/L<br>16.55% | 0 mg/L<br>0% | 0.01 mg/L<br>4.57% | 0.03 mg/L<br>15.64% |
| CSF2 | 80 | 2.49 | 0.05 mg/L<br>2.07% | 0.06 mg/L<br>2.22% | 0 mg/L<br>0% | 0.07 mg/L<br>2.85% |
| CSF3 | 80 | 8.81 | 0.29 mg/L<br>3.25% | 0.29 mg/L<br>3.32% | 0 mg/L<br>0% | 0.38 mg/L<br>4.30% |
| Serum 1 | 80 | 38.5 | 3.84 mg/L<br>9.99% | 0.69 mg/L<br>1.80% | 1.46 mg/L<br>3.81% | 4.17 mg/L<br>10.84% |
| Serum2 | 80 | 1250.1 | 28.87 mg/L<br>2.31% | 21.33 mg/L<br>1.71% | 0 mg/L<br>0% | 35.59 mg/L<br>2.85% |
| Serum3 | 80 | 1935.8 | 55.23 mg/L<br>2.85% | 29.58 mg/L<br>1.53% | 10.23 mg/L<br>0.53% | 63.48 mg/L<br>3.28% |

# OLLI D

# Conclusion:

As summarized, the modification to the iMMAGE IGMLC Reagent is substantially equivalent to the originally cleared product (K993547). Substantial equivalence has been demonstrated through performance to verify that the device functions as intended and that design specifications have been satisfied.

This 510(k) summary 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 7, 2014

BECKMAN COULTER. INC. C/O MS. AMANDA BROWN REGULATORY AFFAIRS SPECIALIST 250 S. KRAEMER BLVD M/S E1.2902 BREA, CA 92821

Re: k130122

Trade/Device Name: IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent IMMAGE® Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: CFN, JIX Dated: December 2, 2013 Received: December 3, 2013

Dear Ms. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Amanda Brown

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Maria.M.Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K130122

## Device Name

IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent

### Indications for Use (Describe)

IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Immunoglobulin M (IGMLC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/13 description: The image shows the name "Elizabeth FDA Stafford -S" in a bold, sans-serif font. The word "Elizabeth" is on the left, followed by the letters "FDA" in a decorative, stylized font. The name "Stafford" is to the right of "FDA", and the letter "S" is on the far right.

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K130122

### Device Name

IMMAGE® Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

### Indications for Use (Describe)

CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

.

Image /page/7/Picture/13 description: The image shows the name "Elizabeth A Stafford -S" in black font. The "A" is stylized with a pattern inside the letter. The text is horizontally oriented and appears to be a signature or nameplate.

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.