TINA-QUANT TRANSFERRIN VER.2

K012393 · Roche Diagnostics Corp. · DDG · Sep 19, 2001 · Immunology

Device Facts

• Record ID: K012393
• Device Name: TINA-QUANT TRANSFERRIN VER.2
• Applicant: Roche Diagnostics Corp.
• Product Code: DDG · Immunology
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Device Story

Tina-quant Transferrin ver.2 is an in vitro diagnostic reagent system for use on COBAS Integra clinical chemistry analyzers. It utilizes immunological agglutination; human transferrin in patient serum or plasma samples forms a precipitate with specific antiserum. This precipitate is measured turbidimetrically at 340 nm. The system provides quantitative results to clinicians to assist in diagnosing malnutrition, inflammation, infection, and iron deficiency anemia. It is intended for professional use in clinical laboratory settings. The device includes a 'High Activity' check to identify potential interference from IgM gammopathy (Waldenstroem), requiring post-dilution for accurate results.

Clinical Evidence

Bench testing only. Performance compared to predicate using clinical samples. Intra-assay precision CV 0.77–0.86%; between-day precision CV 1.8–1.9%. Analytical sensitivity (LDL) 0.013 g/L. Method comparison yielded y = 1.06x + 0.03 (r=0.996). Interference testing showed no significant impact from icterus, hemolysis, lipemia (up to 500 mg/dL), or rheumatoid factors.

Technological Characteristics

Immunoturbidimetric assay; utilizes specific antiserum for agglutination; measured at 340 nm. Standardized against CRM 470 (RPPHS). Designed for use on COBAS Integra clinical chemistry analyzers. Measuring range 1.3–520 mg/dL.

Indications for Use

Indicated for quantitative measurement of human transferrin in serum and plasma to aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia).

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• COBAS Integra Tina-quant Transferrin (K951595)

Submission Summary (Full Text)

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| 510(k) Summary | K012393 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Road<br>Indianapolis, IN 46250<br>(317) 521 - 3831<br><br>Contact Person: Sherri L. Coenen<br><br>Date Prepared: July 25, 2001 |
| Device Name | Proprietary name: Tina-quant Transferrin ver.2<br><br>Common name: Transferrin<br><br>Classification name: Transferrin immunological test system |
| Device Description | The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm. |
| Intended use | The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum. |
| Indications for Use | A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. |

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## 510(k) Summary, Continued

Substantial Equivalence The Tina-quant Transferrin ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the COBAS Integra Tina-quant Transferrin (K951595).

Substantial equivalence similarities

The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.

| Feature | Tina-quant Transferrin<br>ver.2 | Transferrin |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS<br>Integra Tina-quant<br>Trasferrin ver.2 (TRSF2)<br>contains an in vitro<br>diagnostic reagent system<br>intended for use on<br>COBAS Integra systems<br>for the quantitative<br>immunological<br>determination of human<br>transferrin in serum. | The cassette COBAS<br>Integra Transferrin<br>(TRSF) contains an in<br>vitro diagnostic reagent<br>system intended for use<br>on COBAS Integra<br>systems for the<br>quantitative<br>immunological<br>determination of human<br>transferrin in serum. |
| Indication for Use | A transferrin<br>immunological test system<br>is a device that consists of<br>the reagents used to<br>measure by<br>immunological<br>techniques the transferrin<br>(an iron-binding and<br>transporting serum protein)<br>in serum and plasma.<br>Measurement of<br>transferrin levels aids in<br>the diagnosis of<br>malnutrition,acute<br>inflammation, infection,<br>and red blood cell<br>disorders,such as iron<br>deficiency anemia. | A transferrin<br>immunological test<br>system is a device that<br>consists of the reagents<br>used to measure by<br>immunochemical<br>techniques the<br>transferrin (an iron-<br>binding and<br>transporting serum<br>protein) in serum,<br>plasma, and other body<br>fluids. Measurement of<br>transferrin levels aids in<br>the diagnosis of<br>malnutrition, acute<br>inflammation, infection,<br>and red blood cell<br>disorders, such as iron<br>deficiency anemia. |

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## 510(k) Summary, Continued

Substantial equivalence similarities

The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.

| Feature | Tina-quant Transferrin<br>ver.2 | Transferrin |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Protocol | Immunoturbidimetric<br>assay | Immunoturbidimetric<br>assay |
| Instrument | COBAS Integra Clinical<br>Chemistry Analyzers | COBAS Integra<br>Clinical Chemistry<br>Analyzers |
| Traceability /<br>Standardization | Standardized against the<br>reference preparation<br>CRM 470, corresponding<br>to RPPHS (Reference<br>Preparation Protein in<br>Human Serum) | Standardized against<br>the reference<br>preparation CRM 470,<br>corresponding to<br>RPPHS (Reference<br>Preparation Protein in<br>Human Serum) |

#### Substantial equivalence differences

The following table compares the Tina-quant Transferrin ver.2 Assay with the predicate device.

| Feature | Tina-quant<br>Transferrin ver.2 | Transferrin |
|-----------------|---------------------------------|-----------------|
| Sample Type | Human serum and<br>plasma | Human serum |
| Measuring Range | 1.3 - 520 mg/dL | 80 – 1280 mg/dL |

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Substantial equivalence – performance characteristics, cont.

The performance characteristics of the Tina-quant Transferrin ver.2 Assay and the predicate device are compared in the table below. .

| Feature | Tina-quant Transferrin<br>ver.2 | Transferrin |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intra-assay<br>precision (% CV) | 0.86% at 1.35 g/L<br>0.77% at 3.36 g/L | 1.5% at 1.10 g/L<br>0.83% at 3.32 g/L |
| Between Day<br>Precision (% CV) | 1.8% at 1.32 g/L<br>1.9% at 3.70 g/L | 1.6% at 1.10 g/L<br>0.97% at 3.32 g/L |
| Limitations | Icterus: No significant interference Hemolysis: No significant interference Lipemia: No significant interference up to an Intralipid level of 500 mg/dL Rheumatoid factors: No significant interference Interference of Gammopathy type IgM (Waldenstroem) sera is recognized by the “High Activity” check. In case samples are flagged “High Act”, correct results can be obtained after post-dilution. | Icterus: No significant interference Hemolysis: No significant Lipemia: No significant interference Rheumatoid factors: No significant interference |
| Analytical<br>sensitivity (LDL) | 0.013 g/L | 0.58 g/L |
| Method<br>comparison | Tina-quant Transferrin ver.2 (Y) / COBAS Integra Transferrin (X)<br>$y = 1.06x + 0.03$ $r = 0.996$ | Transferrin (Y) / nephelometric determination (X)<br>$y = 1.06x + 0.01 g/L$ $r = 0.958$ |

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Substantial equivalence performance characteristics, cont.

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The performance characteristics of the Tina-quant Transferrin The porcennance the predicate device are compared in the table below.

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| Feature | Tina-quant Transferrin<br>ver.2 | Transferrin |
|--------------------------|---------------------------------|---------------------------------|
| Calibration<br>frequency | • after reagent lot change | • after reagent lot change |
| Expected values | 2.0 – 3.6 g/l (200 – 360 mg/dl) | 2.0 – 3.6 g/l (200 – 360 mg/dl) |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

# SEP 1 9 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K012393 Re:

> Trade Name: Roche Diagnostics Tina-quant® Transferrin ver.2 Regulatory Class: 21 CFR § 866.5880 Regulatory Class: II Product Code: DDG Dated: July 25, 2001 Received: July 27, 2001

Dear Ms. Coenen:

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, 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 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 regulatory action. In addition, FDA may publish further announcements 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.

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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 nouticate 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 If you desire specific darices), please contact the Office of Compliance at additionally 607.10 for in This angliestions on the promotion and advertising of your device, (201) 59 rttact 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 mormation on your responsibility on sumer Assistance at its toll-free number [phone] or 1101) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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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### Indications for Use Statement

Roche Diagnostics Corp.

510(k) Number (if known): K012393

Device Name: Tina-quant Transferrin ver.2

Indications For Use:

The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Soumen S. Altare

Ivision Sian-Off Division of Clinical Laboratory Devices

510(k) Number K012393