DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368

K032692 · Dako A/S · JZG · Jan 22, 2004 · Immunology

Device Facts

• Record ID: K032692
• Device Name: DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
• Applicant: Dako A/S
• Product Code: JZG · Immunology
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

For in vitro diagnostic use. DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

Device Story

Microparticle immunoassay for quantitative determination of beta-2-microglobulin (B2M) in human serum and plasma. Kit contains polystyrene particles coupled with polyclonal rabbit anti-human B2M antibodies. Patient specimen mixed with particles; reaction forms agglutinates measured via rate nephelometry on Beckman Coulter IMMAGE® immunochemistry system. Concentration determined by interpolation of calibration curve. Used in clinical laboratory settings by trained personnel. Output provides B2M concentration levels to assist clinicians in diagnosing rheumatoid arthritis and kidney disease.

Clinical Evidence

Bench testing only. Precision evaluated using modified NCCLS EP10-A2 (total CV 3.8-5.3%). Linearity established from 0.5-20 mg/L (r=0.997). Method comparison with predicate (n=65) showed slope 1.17, intercept 0.70, r=0.997. Matrix comparison (serum vs EDTA/heparin plasma) showed high correlation (r > 0.996). No clinical sensitivity or specificity data provided.

Technological Characteristics

Microparticle immunoassay; polystyrene particles coupled with polyclonal rabbit anti-human B2M antibody. Detection via rate nephelometry. Energy source: IMMAGE® immunochemistry system. Reagents preserved with sodium azide. Calibration via internal reference material. Software: embedded instrument-specific processing.

Indications for Use

Indicated for quantitative determination of beta-2-microglobulin in human serum and plasma to aid in the diagnosis of patients with active rheumatoid arthritis and kidney 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

• IMx B2 Microglobulin (K890421)

Submission Summary (Full Text)

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- 1 510(k) Summary
November 25, 2003 Date of Summary Preparation: Ms. Gitte Brinkmann 1.2 Submitter:

DakoCytomation Denmark A/S. Produktionsvej 42 DK-2600 Glostrup Denmark

- DakoCytomation Beta-2-Microglobulin Kit. 1.3 Trade Name:
- Classification Name, Product Code, Class, Classification Reference: 1.4

| Classification Name | Product Code | Class | 21CFR § |
|------------------------------------------------------|--------------|-------|----------|
| System, Test, Beta-2-<br>Microglobulin Immunological | JZG | II | 866.5630 |

Standards/Special Controls: 1.5

None

Indications for Use: 1.6

For in vitro diagnostic use.

DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

1.7 Device Description:

DakoCytomation Beta-2-Microglobulin Kit is an in vitro diagnostic assay device for the quantitative determination of human beta-2-microglobulin. Beta-2-microglobulin (B2M), a low molecular weight polypeptide of 11,800 daltons, is the light chain component of the major histocompatibility antigen (HLA). B2M is present on the membrane surface of all cells that express major histocompatibility antigens and it is normally present in the circulation as a result of cell membrane turnover.

The Beta-2-Microglobulin device is similar in design, materials and intended use to other 510(k) cleared devices, which are in commercial distribution.

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Substantially Equivalent Commercially Available Devices: 1.8

The Beta-2-Microglobulin device is substantially equivalent to the predicate device described herein with respect to indications for use, device design, materials, and method of manufacture: IMx B2 Microglobulin - K890421

The predicate device is commercially available and a marketed Class II device indicated for use for the quantitative measurement of beta-2-microglobulin in human serum, plasma or urine.

#### Substantial Equivalence Comparison: 1.9

Beta-2-Microglobulin is similar to commercially available device with respect to intended use, material, design and operational principles as follows:

| Similarities | | |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | New device<br>DakoCytomation Beta-2-<br>Microglobulin Kit | Predicate device<br>IMx B2 Microglobulin |
| Intended Use | Quantitative determination<br>of beta-2-microglobulin in<br>human serum and plasma<br>by rate nephelometry on<br>IMMAGE®<br>Immunochemistry<br>Systems. Measurement<br>of beta-2-microglobulin<br>aids in the diagnosis of<br>patients with active<br>rheumatoid arthritis and<br>kidney disease. | Quantitative measurement<br>of beta-2-microglobulin in<br>human serum, plasma or<br>urine to be used as an aid<br>in the management of<br>patients with renal<br>dysfunction or rheumatoid<br>arthritis |
| Sample Type | Serum, plasma | Serum, plasma, urine |

| able<br>T | |
|-----------|--|
|-----------|--|

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| Feature | New device<br>DakoCytomation Beta-2-<br>Microglobulin Kit | Predicate device<br>IMx B2 Microglobulin |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interfering Substances | Hemoglobin<br>concentrations up to 1000<br>mg/dL, bilirubin<br>(conjugated) up to 60<br>mg/dL and triglyceride up<br>to 1500 mg/dL do not<br>significantly interfere with<br>the assay.<br>No significant interference<br>is defined as recovery<br>within $\pm$ 10% at β2M > 6<br>mg/L or within $\pm$ 0.6 mg/L<br>at β2M ≤ 6 mg/L. | Hemoglobin<br>concentrations up to 1000<br>mg/dL, bilirubin<br>(conjugated) up to 41.9<br>mg/dL and triglyceride up<br>to 1023 mg/dL do not<br>significantly interfere with<br>the assay |
| Specificity | b-2-microglobulin | b-2-microglobulin |
| Reagents/Calibrators/Controls | Liquid stable | Liquid stable |

| Feature | DakoCytomation Beta-2-<br>Microglobulin Kit | IMx B2 Microglobulin |
|----------------------------------|---------------------------------------------|-----------------------------|
| Instrument Required | Beckman Coulter IMMAGE | Abbott IMx |
| Antibody | Polyclonal | Monoclonal |
| Sample type | Serum, plasma | Serum , plasma and urine |
| Reaction Test Principle | Nephelometry | MEIA |
| Assay Type | Homogenous Immunoassay | Heterogenous<br>Immunoassay |
| Lower Detection Limit<br>(Serum) | 0.3 mg/L | 0.05 mg/L |
| Assay Range (Serum) | 0.3 to 20 mg/L | 0 to 40 mg/L |

### Indications and Contraindications:

Relative indications and contraindications for DakoCytomation Beta-2-Microglobulin Kit and commercially available devices for similar intended uses are the same.

#### Conclusion: 1.11

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, DakoCytomation concludes that the new device, DakoCytomation Beta-2-Microglobulin Kit, is safe, effective and substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 2 2004

Ms. Gitte Brinkmann QA Professional DakoCytomation Denmark A/S Produktionsvej 42 DK-2600Glostrup Denmark CVR N0. 33 21 13 17

k032692 Re:

Trade/Device Name: DakoCytomation Beta-2-Microglobulin Kit Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-microglobulin immunological test system Regulatory Class: Class II Product Code: JZG Dated: November 25, 2003 Received: November 28, 2003

Dear Ms. Brinkmann:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Aven Autman, m.D.

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# 510(k) Number: K032692

## Statement of Indication for Use

Device Name: DakoCytomation Beta-2-Microglobulin Kit

Indications for Use:

:

For in vitro diagnostic use.

DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Reeves

sion Sign-O Division of Clinical Laboratory Devices

510(k) Number k 0 3 26 62

Prescription Use V

OR

Over-The-Counter Use ___

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