TINA-QUANT COMPLEMENT C3C TEST SYSTEM

K012361 · Roche Diagnostics Corp. · CZW · Nov 29, 2001 · Immunology

Device Facts

• Record ID: K012361
• Device Name: TINA-QUANT COMPLEMENT C3C TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: CZW · Immunology
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

For the in vitro quantitative immunological determination of human complement C3c in serum and plasma.

Device Story

The Tina-quant Complement C3c ver.2 Test System is an in vitro diagnostic assay used to measure human complement C3c concentrations in serum and plasma samples. The device operates on the principle of immunoturbidimetry; human C3c in the sample reacts with a specific antiserum to form a precipitate. The resulting turbidity is measured spectrophotometrically at 340/659 nm on COBAS Integra analyzers. The concentration of C3c is evaluated as a parameter for complement system activation. The test is intended for use by clinical laboratory professionals to assist in diagnosing immunologic disorders related to complement deficiencies. The output is a quantitative measurement of C3c, which clinicians use to assess patient immune status and guide clinical decision-making regarding potential immunologic pathologies.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance comparisons, including measuring range, analytical sensitivity, and sample type compatibility.

Technological Characteristics

Immunoturbidimetric assay; utilizes specific antiserum for C3c precipitation; measured via spectrophotometry at 340/659 nm; designed for use on COBAS Integra automated analyzers; sample types include human serum and plasma.

Indications for Use

Indicated for in vitro quantitative immunological determination of human complement C3c in serum and plasma to aid in the diagnosis of immunologic disorders, particularly those associated with complement component deficiencies.

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 C3c Test System (K951595)

Submission Summary (Full Text)

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# NOV 2 9 2001

## 510(k) Summary

| Introduction | According to the requirements established in the Food and Drug<br>Administration's guidance document entitled "The New 510(k) Paradigm:<br>Alternate Approaches to Demonstrating Substantial Equivalence in Premarket<br>Notifications", the following information provides sufficient detail to<br>understand the basis for a determination of substantial equivalence. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Helen T. Torney<br>Date Prepared: November 12, 2001 |
| 2) Device name | Proprietary name: Tina-quant Complement C3c Test System<br>Common name: Complement C3c Test<br>Classification name: Complement components immunological test system |
| 3) Predicate<br>device | We claim substantial equivalence to the currently marketed Tina-quant<br>Complement C3c Test System on Roche COBAS Integra Analyzers<br>(K591595). |

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### 510(k) Summary, Continued

| 4) Device<br>Description | The Tina-quant Complement C3c ver.2 Test System is based on the activation<br>of the complement system which takes place via a classical and an alternative<br>route. The two pathways come together in a joint terminal path. As a<br>complement factor C3 is a factor common to both pathways, the<br>concentration of C3 and its degradation products (including C3c) can be<br>evaluated as a parameter for activation of the complement system. Human<br>C3c forms a precipitate with a specific antiserum which is determined<br>turbidimetrically. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | For the in vitro quantitative immunological determination of human<br>complement C3c in serum and plasma. |
| 6.) Substantial<br>equivalence | The table below indicates the similarities between the modified Tina-quant<br>Complement C3c ver.2 Test System on COBAS Integra analyzers and the<br>predicate, Tina-quant Complement C3c Test System on COBAS Integra<br>analyzers (K951595). In summary, the Tina-quant Complement C3c ver.2<br>Test System described in this submission is, in our opinion, substantially<br>equivalent to the predicate device.<br>Comparison of Proposed and Predicate Device |

| Topic | Modified<br>Tina-quant<br>Complement C3c ver.2 | Tina-quant Complement C3c<br>(cleared K951595) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro<br>quantitative<br>immunological<br>determination of human<br>complement C3c in serum<br>and plasma. | For the in vitro quantitative<br>immunological determination of<br>human complement C3c in serum. |
| Indication for Use | Measurements of these<br>proteins aid in the<br>diagnosis of immunologic<br>disorders, especially those<br>associated with<br>deficiencies of<br>complement components. | Measurements of these proteins aid<br>in the diagnosis of immunologic<br>disorders, especially those associated<br>with deficiencies of complement<br>components. |
| Sample Type | Human serum and plasma | Human serum |
| Analytical Sensitivity | 0.11 g/L (11 mg/dL) | 0.262 g/L (26mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |

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| Topic | Modified<br>Tina-quant<br>Complement C3c ver.2 | Tina-quant Complement C3c<br>(cleared K951595) |
|-----------------|------------------------------------------------|------------------------------------------------|
| Measuring Range | 0.11-6.0 g/L (11-600<br>mg/dL) | 0.55-8.9 g/L (55-890 mg/dL) |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal 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: k012361

Trade/Device Name: Tina-Quant Complement C3c ver.2 Test System Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW Dated: November 12, 2001 Received: November 14, 2001

Dear Ms. Torney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection b retar pe issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence phor to May 20, 1978, in example with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (1101) that do not request of the general controls provisions of the Act. The T ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 IT your device is olassified (600 as controls. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devisou that I Dr unation that your device complies with other requirements of the Act that I DTT has made a actern regulations administered by other Federal agencies. You must or any I catales and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 6075, accems (21 CFR Part 820); and if applicable, the electronic forth in the quind) byers provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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 Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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): KOI236 | Device Name: Tina-quant Complement C3c ver.2 Test System

Indications for Use:

For the in vitro quantitative immunological determination of human complement C3cin serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan S. Altare

vision Sign-Off) vision of Clineal Laboratory Devices

510(k) Number K012361

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)