TINA-QUANT COMPLEMENT C4 TEST SYSTEM

K012359 · Roche Diagnostics Corp. · DBI · Nov 29, 2001 · Immunology

Device Facts

• Record ID: K012359
• Device Name: TINA-QUANT COMPLEMENT C4 TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: DBI · Immunology
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma.

Device Story

Tina-quant Complement C4 ver.2 Test System is an in vitro diagnostic reagent system for use on COBAS INTEGRA analyzers. The device measures human complement C4 levels in serum and plasma samples. Principle of operation involves the formation of a precipitate between human C4 and a specific antiserum, which is then measured turbidimetrically. The system is operated by laboratory personnel in a clinical setting. Output is a quantitative measurement of C4 concentration, which healthcare providers use to assist in the diagnosis and monitoring of autoimmune diseases, infections, and inflammatory disorders. The device provides a diagnostic aid to clinicians, potentially facilitating timely clinical decision-making for patients with suspected immune-related conditions.

Clinical Evidence

Bench testing only. The submission provides analytical performance data comparing the modified Tina-quant Complement C4 ver.2 Test System to the predicate device, including measuring range (0.04-1.35 g/L) and analytical sensitivity (0.04 g/L). No clinical prospective or retrospective studies were required for this 510(k) clearance.

Technological Characteristics

Turbidimetric immunoassay reagent system. Utilizes specific antiserum to form precipitate with human C4. Designed for use on COBAS INTEGRA automated analyzer platforms. Wavelength: 340/659 nm. Measuring range: 0.04-1.35 g/L.

Indications for Use

Indicated for the quantitative determination of human complement C4 in serum and plasma to aid in detecting the presence and level of C4 found in autoimmune diseases, infections, and inflammatory disorders.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Predicate Devices

• Tina-quant Complement C4 Test System (K951595)

Submission Summary (Full Text)

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NOV 2 9 2001 510(k) Summary According to the requirements established in the Food and Drug Introduction Administration's guidance document entitled "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications", the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. Indianapolis, IN 46250 contact [phone] Contact Person: Helen T. Torney Date Prepared: July 23, 2001 Tina-quant Complement C4 Test System Proprietary name: 2) Device name Complement C4 Test Common name: Classification name: Complement components immunological test system. We claim substantial equivalence to the currently marketed Tina-quant 3) Predicate Complement C4 Test System on Roche COBAS Integra Analyzers device (K951595)

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## 510(k) Summary, Continued

| 4) Device<br>Description | The Tina-quant Complement C4 Test System is based on the activation of the<br>complement system which takes place via a classical and alternative route.<br>Complement factor C4 participates in activation by the classical route.<br>Human C4 forms a precipitate with a specific antiserum which is determined<br>turbidimetrically. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA<br>systems for the quantitative immunological determination of human<br>complement C4 in serum and plasma. |
| 6.) Substantial<br>equivalence | The table below indicates the similarities between the modified Tina-quant<br>Complement C4 ver.2 Test System on COBAS Integra analyzers and the<br>predicate, Tina-quant Complement C4 Test System Roche (K951595). In<br>summary, the Tina-quant Complement C4 ver.2 Test System described in this<br>submission is, in our opinion, substantially equivalent to the predicate device. |

submission is, in our opinion, substantially equivalent to

| Topic | Modified<br>Tina-quant Complement C4 ver. | Tina-quant Complement C4<br>(cleared K951595) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent system<br>intended for use on COBAS<br>INTEGRA systems for the<br>quantitative immunological<br>determination of human<br>complement C4 in serum and<br>plasma | For the in vitro quantitative<br>immunological determination of<br>human complement C4 in serum and<br>plasma. |
| Indication for Use | Aid in detecting the presence and<br>level of C4 found in autoimmune<br>diseases, infections and<br>inflammatory disorders. | Aid in detecting the presence and<br>level of C4 found in autoimmune<br>diseases, infections and<br>inflammatory disorders. |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |
| Sample Type | Human serum and plasma | Human serum |
| Analytical Sensitivity | 0.04 g/L (4 mg/dL) | 0.012 g/L (1.2mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Measuring Range | 0.04-1.35 g/L<br>(4-135 mg/dL) | 0.06-0.9 g/L<br>(6-90 mg/dL) |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 2 9 2001

Ms. Helen Torney Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k012359

> Trade/Device Name: Tina-Quant Complement C4 ver.2 Test System Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: DBI Dated: October 12, 2001 Received: October 15, 2001

Dear Ms.Torney:

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

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anon-you 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 1 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, [phone]. I readers of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornlactor on Jour responsible 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): V(012359 Device Name: Tina-quant Complement C4 ver.2 Test System

Indications for Use:

In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the In viti o diagnostic reague of buman complement C4 in serum and plasma. qualificative inimulations and level of C4 found in autoimmune diseases, infections and inflammatory disorders.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Seisen Altare

sion of Clinical Laboratory Devices

510(k) Number_Kol 2359

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)