MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

K032535 · Roche Diagnostics Corp. · DHR · Sep 10, 2003 · Immunology

Device Facts

• Record ID: K032535
• Device Name: MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: DHR · Immunology
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis.

Device Story

Tina-quant® RF II is a particle-enhanced immunoturbidimetric assay; utilizes latex-bound heat-inactivated IgG as antigen. Input: human serum or plasma samples. Operation: antigen reacts with RF-antibodies in sample to form antigen/antibody complexes; agglutination measured turbidimetrically on automated clinical chemistry analyzers. Output: quantitative RF concentration. Used in clinical laboratory settings by trained technicians. Results interpreted by physicians to aid in rheumatoid arthritis diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance comparisons between the subject and predicate device.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay; latex-bound heat-inactivated IgG reagent. Designed for use on automated clinical chemistry analyzers. Measuring range: 7 - 103 IU/ml.

Indications for Use

Indicated for the in vitro quantitative determination of rheumatoid factors in human serum and 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

• Tina-quant® Rheumatoid Factors II Test System (K002609)

Submission Summary (Full Text)

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SEP 1 0 2003

K032535

# 510(k) Summary - Tina-quant® RF II Test System

| 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 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: August 8, 2003 |
| Device Name | Proprietary name: Tina-quant® Rheumatoid Factors II Test System<br><br>Common name: Tina-quant® RF II<br><br>Classification name: Rheumatoid Factor Test System |
| Device description | The Tina-quant® Rheumatoid Factors II Test System is a particle enhanced immunoturbidimetric assay. Latex-bound heat inactivated IgG (antigen) reacts with the RF-antibodies in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically. |
| Intended use | Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis. |
| Predicate Device | We claim substantial equivalence to the currently marketed Tina-quant® Rheumatoid Factors II Test System. (K002609). |

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## 510(k) Summary - COBAS Integra Creatinine plus ver.2,

continued

The following table describes the similarities and differences between the Reagent Summary Tina-quant® Rheumatoid Factors II Test System and the predicate device.

| Topic | Tina-quant® RF II (K002609) | Tina-quant® RF II (Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the quantitative in vitro determination of rheumatoid factors in human serum on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis. | Immunoturbidimetric assay for the quantitative in vitro determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis. |
| Method | Particle-enhanced<br>immunoturbidimetric assay | Same |
| Sample type | Serum | Serum<br>Li/Na Heparin, Na2/K2/K3 EDTA-<br>Plasma |
| Measuring<br>range | 3 - 120.0 IU/ml | 7 - 103 IU/ml |
| Expected<br>values | < 14 IU/ml | Same |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### SEP 1 0 2003

Re: k032535 Trade/Device Name: Tina-quant® RF II Test System Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: II Product Code: DHR Dated: August 8, 2003 Received: August 18, 2003

Dear Ms. Coenen:

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). 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.

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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,

Steven Sutman

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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#### Indications for Use Statement

| 510(k) Number (if known): | N/A K032535 |
|---------------------------|-------------|
|---------------------------|-------------|

Device Name: Tina-quant® RF II Test System

Indications For Use:

Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis.

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

(Optional Format 1-2-96)

I
Division Sign-Off/

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) H032535