TINAQUANT RHEUMATOID FACTOR ASSAY

K971379 · Boehringer Mannheim Corp. · DHR · Jun 17, 1997 · Immunology

Device Facts

• Record ID: K971379
• Device Name: TINAQUANT RHEUMATOID FACTOR ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: DHR · Immunology
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Tinaquant Rheumatoid Factor assay is an immunoturbidometric assay for the quantitative determination of rheumatoid factor (antibodies to immunoglobulins) in human serum or plasma using automated clinical chemistry analyzers. Measurement of rheumatoid factor may be used as an aid in the diagnosis of rheumatoid arthritis.

Device Story

The Tina-quant Rheumatoid Factor Assay is an in vitro diagnostic test for use on automated clinical chemistry analyzers (e.g., Hitachi 717). The device uses a turbidimetric immunoinhibition (TINIA) principle. Serum or plasma samples are mixed with a buffer (R1) and then reacted with latex particles coated with polyclonal human IgG (R2). Rheumatoid factor in the sample binds to the IgG-coated particles, forming aggregates. The resulting agglutination increases the turbidity of the solution, which is measured as an increase in optical density. The degree of turbidity is directly proportional to the concentration of rheumatoid factor in the sample. The assay provides quantitative results to assist clinicians in the diagnosis of rheumatoid arthritis.

Clinical Evidence

Bench testing only. Performance characteristics compared to the predicate included precision (intra-assay CV 1.1-3.8%; inter-assay CV 2.2-2.6%), lower detection limit (7.5 IU/mL), and linearity (7.5-140 IU/mL). Method comparison (N=35) against the predicate showed a correlation coefficient (r) of 0.880. Interference testing demonstrated no significant error (≤10%) for bilirubin (30 mg/dL), hemoglobin (20 g/L), and lipemia (2000 mg/dL).

Technological Characteristics

Immunoturbidimetric assay using latex particles coated with polyclonal human IgG. Operates on automated clinical chemistry analyzers (e.g., Hitachi 717). Measures optical density changes via turbidity. Quantitative in vitro diagnostic reagent system.

Indications for Use

Indicated for the quantitative determination of rheumatoid factor in human serum or plasma to aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• Behring Laser Rf Test - Rheumatoid Factor (S) Reagents (K850296)

Submission Summary (Full Text)

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K971379

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JUN 17 1997

| 510(k) Summary | | Image: boehringer logo |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | |
| 1.<br>Submitter<br>name,<br>address,<br>contact | Boehringer Mannheim Corporation<br>2400 Bisso Lane<br>P.O. Box 4117<br>Concord, CA 94524-4117<br>(510) 674 - 0690, extension 8413<br>Fax: [phone]<br><br>Contact Person: Yvette Lloyd<br>Date Prepared: April 8, 1997 | |
| 2.<br>Device name | Proprietary name: Tina-quant® Rheumatoid Factor Assay<br>Common name: Immunoturbidometric assay for the determination of<br>Rheumatoid Factor.<br>Classification name: Rheumatoid Factor immunological test system | |
| 3.<br>Predicate<br>device | The Boehringer Mannheim Tina-quant® Rheumatoid Factor assay is<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the currently<br>marketed Behring Laser Rf Test - Rheumatoid Factor (S) Reagents<br>(K850296). | |

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# 10(k) Summary, Continued BOEHRING

Image /page/1/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with a white circle inside. The word "boehringer" is written in white inside the circle. The word "mannheim" is written vertically in white on the left side of the black square.

The Rheumatoid Factor determination is based upon turbidimetric 4. immunoinhibition (TINIA) using a serum or plasma blood sample. The Device Description sample containing rheumatoid factor is transferred into a buffer solution (R1 reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal human IgG (anti-human rheumatoid factor antibodies - R2 reagent) is added to mixture of the first step. The antibody-参 coated particles will bind to the rheumatoid factor in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of rheumatoid factor 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 rheumatoid factor in the sample is directly proportional to the amount of turbidity formed. Immunoturbidometric assay for the quantitative in-vitro determination of ડ. Intended use rheumatoid factor. The Boehringer Mannheim Tina-quant® Rheumatoid Factor assay is 6. Comparison substantially equivalent to other products in commercial distribution intended to predicate for similar use. Most notably it is substantially equivalent to the currently device marketed Behring Laser Rf Test - Rheumatoid Factor (S) Reagents (K850296).

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# 0(k) Summary, Continued

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6. Comparison to predicate device cont.

参

The following table compares the Tina-quant® Rheumatoid Factor with the predicate device, Behring Laser Rf Test - Rheumatoid Factor (S) Reagents. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.

#### Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of Rheumatoid Factor.

·Sample type: Serum and plasma

#### Differences:

| Feature | Tina-quant® Rheumatoid<br>Factor | Laser Rf Test - Rheumatoid<br>Factor (S) Reagents |
|----------------------------|----------------------------------|---------------------------------------------------|
| Reaction test<br>principle | Immunoturbidimetric | Laser Nephelometry |
| Instrument<br>required | Hitachi 717 | Behring Laser Nephelometer |

#### Performance Characteristics:

| Feature | Tina-quant® Rheumatoid<br>Factor | Laser Rf Test - Rheumatoid<br>Factor (S) Reagents |
|------------------|----------------------------------|---------------------------------------------------|
| Precision | Intra and InterAssay (IU/mL): | Intra and Interassay (IU/mL): |
| Level | Sample 1 Sample 2 Sample 3 | Low Mid High |
| N | 21 21 21 | 20 20 20 |
| Intra-Assay Mean | 31.9 144.4 645.1 | 52 201 510 |
| %CV | 3.8 1.4 1.1 | range 4.2 to 6.1% |
| Level | Sample 1 Sample 2 | |
| Inter-Assay Mean | 76.4 347.4 | 92 155 306 |
| %CV | 2.6 2.2 | 9.3 6.2 6.6 |

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# BOEHRINGERO(k) Summary, Continued MANNHEIM CORPORATION

Image /page/3/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo is a black square with the word "mannheim" written vertically on the left side. Inside the square is a white circle with the word "boehringer" written horizontally inside the circle.

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Performance Characteristics:

Comparison to predicate device, (cont.)

| Feature | Tina-quant® Rheumatoid<br>Factor | Laser Rf Test -<br>Rheumatoid Factor (S)<br>Reagents |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Lower Detection<br>Limit | 7.5 IU/mL | 10 IU/mL |
| Linearity | 7.5 - 140 IU/mL | 10 - 600 IU/mL |
| Method<br>Comparison | Vs Behring Laser<br>Nephelometer RF<br>Passing/Bablok<br>$y=1.01x-2.30$<br>$r=0.880$<br>SEE=11.20<br>N=35<br><br>Least Squares:<br>$y = 0.90x + 5.11$<br>$r = 0.880$<br>SEE = 15.32<br>N = 35 | Vs NA Latex RF Kit<br>Regression:<br>$y =0.90x - 20$<br>$r=0.975$<br>SEE =44.9<br>N=72 |

参

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## BOEHRINGER O(k) Summary, Continued MANNHEIM CORPORATION

Image /page/4/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with a white circle inside. The word "boehringer" is written in black inside the white circle. The word "mannheim" is written vertically on the left side of the black square.

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Comparison to predicate device, (cont.)

参

## Performance Characteristics:

| Feature | Tina-quant® Rheumatoid<br>Factor | Laser Rf Test - Rheumatoid<br>Factor (S) Reagents |
|------------------------------------|--------------------------------------|---------------------------------------------------|
| Interfering<br>substances | No interference at:<br>(≤ 10% error) | No interference at: |
| Bilirubin<br>Hemoglobin<br>Lipemia | 30 mg/dL<br>20 g/L<br>2000 mg/dL | not tested<br>2 g/dL<br>not tested |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN | 7 1997

Ms. Yvette Lloyd Regulatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane ………………………… Concord, California 94524-4117

K971379 Re:

> Trade Name: Tina-quant® Rheumatoid Factor Reagents 编 Regulatory Class: II Product Code: DHR Dated: April 8, 1997 Received: April 14, 1997

Dear Ms. Lloyd:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 annovacements 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.

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].

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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" (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 Putman

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

Device Name: Tina-quant® Rheumatoid Factor Assay

Indications For Use:

ું કુંદર

The Tinaquant Rheumatoid Factor assay is an immunoturbidometric assay for the quantitative determination of rheumatoid factor (antibodies to immunoglobulins) in human serum or plasma using automated clinical chemistry analyzers. Measurement of rheumatoid factor may be used as an aid in the diagnosis of rheumatoid arthritis.

Peter S. Magrini

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |

(Optional Format 1-2-96)