TINAQUANT B 2-MICROGLOBULIN ASSAY

K980724 · Boehringer Mannheim Corp. · JZG · Oct 16, 1998 · Immunology

Device Facts

• Record ID: K980724
• Device Name: TINAQUANT B 2-MICROGLOBULIN ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: JZG · Immunology
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Indications for Use

Immunological latex agglutination test for the in vitro quantitative determination of ß 2microglobulin in human serum and plasma. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Device Story

Tina-quant® ß 2-microglobulin Assay is an in vitro diagnostic immunoturbidimetric assay. Input: human serum or plasma samples. Process: sample mixed with TRIS buffer (R1) and polyclonal anti-rabbit ß 2-microglobulin antibodies (R2); antibodies bind to ß 2-microglobulin forming aggregates; agglutination complex measured turbidimetrically via increased optical density. Output: quantitative concentration of ß 2-microglobulin. Used in clinical laboratory settings on Hitachi instrumentation. Healthcare providers use results to aid in diagnosing active rheumatoid arthritis and kidney disease.

Clinical Evidence

Bench testing only. Performance evaluated via precision (intra-assay CV 1.0-4.4%, inter-assay CV 2.6-2.7%), linearity (0.20-8.0 mg/L), and lower detection limit (0.05 mg/L). Method comparison against Abbott IMx (N=36) showed correlation (r=0.983, Deming regression y=1.26x-0.15). Interference testing confirmed no significant error (≤10%) with bilirubin, hemoglobin, lipemia, or rheumatoid factor.

Technological Characteristics

Immunoturbidimetric assay; utilizes polyclonal anti-rabbit ß 2-microglobulin antibodies. Requires Hitachi instrumentation for optical density measurement. Quantitative, in vitro diagnostic, standalone laboratory test.

Indications for Use

Indicated for the quantitative determination of ß 2-microglobulin in human serum and plasma to aid in the diagnosis of 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

• Abbott IMx® ß 2-microglobulin assay

Submission Summary (Full Text)

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OCT 16 1998

# 510(k) Summary

K980724

Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1. Submitter name, address, contact | Boehringer Mannheim Corporation<br>P.O. Box 9002<br>Pleasanton, CA 94566-0900<br>[phone]<br>FAX [phone]<br>Contact Person: Betsy Soares-Maddox<br>Date Prepared: February 11, 1998 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Device name | Proprietary name: Tina-quant® ẞ 2-microglobulin Assay<br>Common name: Immunoturbidometric assay for the determination of ẞ 2-microglobulin.<br>Classification name: ẞ 2-microglobulin immunological test system |
| 3. Predicate device | The Boehringer Mannheim Tina-quant® ẞ 2-microglobulin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott IMx® ẞ 2-microglobulin assay. |

Continued on next page

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#### 510(k) Summary, Continued

The ß 2-microglobulin determination is based upon turbidimetric 4. Device immunoinhibition (TINIA) using a serum or plasma blood sample. The Description sample containing B 2-microglobulin is transferred into a TRIS buffer solution (R1 reagent). In the second step, an aliquot of solution of polyclonal antirabbit ß 2-microglobulin antibodies (R2 reagent) is added to mixture of the first step. The antibody will bind to the ß 2-microglobulin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of B 2-microglobulin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ß 2-microglobulin in the sample is directly proportional to the amount of turbidity formed. Immunoturbidometric assay for the quantitative in-vitro determination of ß 2-ಳು Intended use microglobulin. The Boehringer Mannheim Tina-quant® ß 2-microglobulin is substantially 6. Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Abbott IMx® ß 2-microglobulin assay. Continued on next page

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### 510(k) Summary, Continued

6.

Comparison to predicate device cont.

The following table compares the Tina-quant® ß 2-microglobulin with the predicate device, Abbott IMx ® ß 2-microglobulin assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.

#### Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of ß 2-microglobulin

#### Differences:

| Feature | Tina-quant® ß 2-<br>microglobulin | Abbott IMx® ß 2-<br>microglobulin |
|----------------------------|-----------------------------------|-----------------------------------|
| Sample Type | Serum and Plasma | Serum, Plasma, and Urine |
| Reaction test<br>principle | Immunoturbidimetric | Microparticle |
| Instrument<br>required | Hitachi | Abbott IMx |

#### Performance Characteristics:

| Feature | | Tina-quant® β 2-<br>microglobulin | | Abbott IMx® β 2-<br>microglobulin | | | |
|--------------------------|------------------------------|-----------------------------------|------------------------------|-----------------------------------|----------|-----|------|
| Precision | Intra and InterAssay (mg/l): | | Intra and InterAssay (mg/L): | | | | |
| | Level | Low | Mid | High | Low | Mid | High |
| | N | 21 | 21 | 21 | 12 | 12 | 12 |
| Intra-Assay | Mean | 0.57 | 2.26 | 7.75 | 1.7 | 3.9 | 9.7 |
| | %CV | 4.4 | 1.9 | 1.0 | 6.0 | 4.4 | 4.9 |
| | Level | Sample 1 | Sample 2 | | Low | Mid | High |
| | N | 21 | 21 | | 90 | 90 | 90 |
| Inter-Assay | Mean | 1.16 | 4.70 | | 1.7 | 3.9 | 9.7 |
| | %CV | 2.6 | 2.7 | | 9.2 | 6.8 | 7.3 |
| Lower Detection<br>Limit | | 0.05 mg/L | | | 0.5 µg/L | | |

Continued on next page

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## 510(k) Summary, Continued

6.

Performance Characteristics:

Comparison to predicate device, (cont.)

| Feature | Tina-quant® β 2-<br>microglobulin | Abbott IMx® β 2-<br>microglobulin |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Linearity | 0.20 - 8.0 mg/L | --- |
| Method<br>Comparison | Vs Abbott IMx® β 2-<br>microglobulin<br>Deming's<br>$y=1.26 x - 0.15$<br>r=0.983<br>SEE =0.23<br>N=36<br><br>Least Squares:<br>$y = 1.24x - 0.11$<br>r = 0.983<br>SEE = 0.32<br>N = 36 | --- |
| Interfering<br>substances | No interference at:<br>(≤ 10% error)<br><br>Bilirubin 20 mg/dL<br>Hemoglobin 500 mg/dL<br>Lipemia 1500 mg/dL<br>Rheumatoid<br>Factor 200 IU/mL | --- |
| Specificity | Specific for β 2-<br>microglobulin | Specific for β 2-<br>microglobulin |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the logo in a circular fashion.

OCT 16 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Betsy Soares-Maddox Manager, Regulatory Affairs and Quality Assurance Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

K980724/S1 Re: Trade Name: Tina-quant® ß 2-microglobulin Assay Requlatory Class: II Product Code: JZG Dated: August 31, 1998 Received: September 1, 1998

Dear Ms. Soares-Maddox:

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, listinq 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 Requlations. 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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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Page 2

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 requlation 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 [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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510(k) Number (if known): N/A

K980724

Device Name: Tina-quant® ß 2-microglobulin Assay

Indications For Use:

Intended use

Immunological latex agglutination test for the in vitro quantitative determination of ß 2microglobulin in human serum and plasma.

Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> | OR Over-The-Counter Use | <div> <span style="text-decoration: overline;"></span> </div> |
|----------------------|----------------------------------------------------------------|--------------------------|---------------------------------------------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | |

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