TINA-QUANT TRANSFERRIN VER.2

K012371 · Roche Diagnostics Corp. · DDG · Sep 19, 2001 · Immunology

Device Facts

• Record ID: K012371
• 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

Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. 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 immunoturbidimetric assay for use on automated clinical chemistry analyzers. The device utilizes rabbit anti-transferrin antibodies to react with transferrin in human serum or plasma samples, forming antigen/antibody complexes. Polyethylene glycol (PEG) is added to accelerate the reaction and enhance sensitivity. The resulting agglutination is measured turbidimetrically. The assay is performed in clinical laboratory settings by trained technicians. Results are provided to physicians to assist in diagnosing conditions related to iron metabolism, such as malnutrition, inflammation, infection, and anemia. The device provides quantitative measurements of transferrin levels, which are compared against reference ranges to inform clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (intra-assay CV 1.0-2.7%, between-day CV 0.0-1.7%), analytical sensitivity (0.007-0.02 g/l), and method comparison against the predicate (Passing/Bablock regression: y = 0.01 + 0.97x, r = 0.990). Interference testing performed for icterus, hemolysis, lipemia, and rheumatoid factors.

Technological Characteristics

Immunoturbidimetric assay; reagents include rabbit anti-transferrin antibodies and PEG. Standardized against CRM 470/RPPHS. Designed for use on automated clinical chemistry analyzers (e.g., Roche/Hitachi series). Measuring range 0.007-7.80 g/l depending on instrument. Software-controlled automated analysis.

Indications for Use

Indicated for the quantitative determination of transferrin in human 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

• Tina-quant Transferrin (K012371)

Submission Summary (Full Text)

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#### 510(k) Summary

#### SEP 1 9 2001

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics Corporation name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 576 - 3544 Contact Person: Sherri L. Coenen Date Prepared: July 26, 2001 Device Name Proprietary name: Tina-quant Transferrin ver.2 Common name: Transferrin Classification name: Transferrin immunological test system The Tina-quant Transferrin ver.2 Assay is based on the principle of Device Description immunological agglutination. Anti-transferrin antibodies react with the antigen in the sample to form an antigen/antibody complex. Following agglutination, this is measured turbidimetrically. Addition of PEG allows the

reaction to progress rapidly to the end point and increases sensitivity.

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Substantial equivalence similarities

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

| Feature | Tina-quant Transferrin<br>ver.2 | Tina-quant Transferrin |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidometric<br>assay for the in vitro<br>quantitative determination<br>of transferrin in human<br>serum and plasma on<br>automated clinical<br>chemistry analyzers. | Immunoturbidometric<br>assay for the in vitro<br>quantitative determination<br>of transferrin in human<br>serum and plasma on<br>automated clinical<br>chemistry analyzers. |
| 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 system<br>is a device that consists of<br>the reagents used to<br>measure by<br>immunochemical<br>techniques the transferrin<br>(an iron-binding and<br>transporting serum<br>protein) in serum, plasma,<br>and other body fluids.<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. |
| Assay Protocol<br>Instrument | Immunoturbidimetric<br>Roche/Hitachi Clinical<br>Chemistry Analyzers | Immunoturbidimetric<br>Roche/Hitachi Clinical<br>Chemistry Analyzers |
| Sample Type | Human serum and plasma | Human serum and plasma |
| 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 the<br>reference preparation<br>CRM 470, corresponding<br>to RPPHS (Reference<br>Preparation Protein in<br>Human Serum) |
| Feature | Tina-quant Transferrin ver.2 | Tina-quant Transferrin |
| Antibody source | rabbit | goat |
| Measuring Range | Roche/Hitachi 704/902<br>0.02 - 5.00 g/l<br>(1 - 500 mg/dl)<br>Maximum reportable range is dependent on the highest<br>standard concentration. | Roche/Hitachi 704/902<br>80 - 500 mg/dl<br>Maximum reportable range is<br>dependent on the highest<br>standard concentration. |
| | Roche/Hitachi 717/747<br>0.02 - 5.00 g/l<br>(1 - 500 mg/dl)<br>Extended measuring<br>range with rerun<br>0.02 - 7.50 g/l<br>(1 - 750 mg/dl)<br>Maximum reportable range<br>is dependent on the highest<br>standard concentration. | Roche/Hitachi<br>717/747/914<br>80 - 500 mg/dl<br>Extended measuring<br>range with rerun<br>80 - 1000 mg/dl<br>Maximum reportable range is<br>dependent on the highest<br>standard concentration. |
| | Roche/Hitachi<br>904/911/912/917/<br>Modular P<br>0.007 - 5.20 g/l<br>(0.7 - 520<br>mg/dl)<br>Extended measuring<br>range with rerun<br>0.007 - 7.80 g/l<br>(0.7 - 780<br>mg/dl)<br>Maximum reportable range<br>is dependent on the highest<br>standard concentration | Roche/Hitachi<br>904/911/912/917/<br>Modular P<br>15 - 500 mg/dl<br>Maximum reportable range is<br>dependent on the highest<br>standard concentration. |

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Substantial equivalence differences

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

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#### Substantial equivalence – performance characteristics

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 | Tina-quant Transferrin |
|------------------------------------|---------------------------------------------|----------------------------------|
| Intra-assay<br>precision (%<br>CV) | Human sera:<br>1.0% at 1.36 g/l (136 mg/dl) | Human sera:<br>0.8% at 169 mg/dl |
| | 2.7% at 3.59 g/l (359 mg/dl) | |
| | Controls:<br>2.1% at 2.90 g/l (290 mg/dl) | Controls:<br>0.8% at 217 mg/dl |
| | 1.0% at 4.31 g/l (431 mg/dl) | 0.8% at 403 mg/dl |
| Between Day<br>Precision (%<br>CV) | Human sera:<br>0.0% at 1.60 g/l (160 mg/dl) | Human sera:<br>3.0% at 169 mg/dl |
| | 1.4% at 3.38 g/l (338 mg/dl) | |
| | Controls:<br>1.7% at 2.88 g/l (288 mg/dl) | Controls:<br>1.4% at 217 mg/dl |
| | 1.4% at 4.35 g/l (435 mg/dl) | 1.5% at 403 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 | Tina-quant Transferrin |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | Icterus: No significant interference with up to an I index of 60 Hemolysis: No significant interference up to an H index of 1000 Lipemia (Intralipid): No significant interference up to an L index of 500 Rheumatoid factors < 1200 IU/ml do not interfere Gammopathy type IgM sera (Waldenstroem's macroglobulinemia) interfere with the assay | Icterus: No significant interference from bilirubin up to an I index of 60 Hemolysis: No significant interference from hemoglobin up to an H index of 1000 Lipemia (Intralipid): No significant interference from lipemia up to an L index of 600 Rheumatoid factors < 350 IU/ml do not interfere |
| Analytical<br>sensitivity<br>(LDL) | Roche/Hitachi<br>704/717/747/902<br>0.02 g/l (1 mg/dl)<br><br>Roche/Hitachi<br>904/911/912/917/Modular P<br>0.007 g/l (0.7 mg/dl) | 15 mg/dl |
| Method<br>comparison | Tina-quant Transferrin ver.2 (Y) / Tina-quant Transferrin (X):<br>Passing/Bablock:<br>$y = 0.01 + 0.97x$<br>$r = 0.990$ | Tina-quant Transferrin on Roche/Hitachi 917 (Y)/<br>Tina-quant Transferrin on Roche/Hitachi 911 (X):<br>Passing/Bablock:<br>$y = 1.141 + 0.989x$<br>$r = 0.998$ |

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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.

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| Feature | Tina-quant Transferrin<br>ver.2 | Tina-quant Transferrin |
|--------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Calibration<br>frequency | • after reagent lot change<br>• as required following<br>quality control procedures | • after reagent lot<br>change<br>• as required following<br>quality control<br>procedures |
| Expected values | 2.0 – 3.6 g/l (200 – 360 mg/dl) | IFCC/CRM 470:<br>200 – 360 mg/dl<br>Roche:<br>200 – 400 mg/dl |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with wavy lines extending from the bottom of the profiles.

### 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

K012371 Re:

Trade Name: Roche Diagnostics Tina-quant® Transferrin ver.2 Regulatory Class: 21 CFR § 866.5880 Regulatory Class: II Product Code: DDG Dated: July 26, 2001 Received: July 26, 2001

Dear Ms. Coenen:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally be is substantially equivalent (for the indications for use above and we nave acteriner actived predicate devices marketed in interstate commerce stated in the citems. To logally manote of the Medical Device Amendments, or to devices that provision in the may 20, 1910, the encounters. with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (1100). Tou may) accessors) sprovisions of the Act include requirements for annual provisions of the Fee. "The est, 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 (1 remarket rippt vary of the Code of Federal Regulations, Title 21, Parts 800 to 895. arretung your as novelent determination assumes compliance with the Current Good A substantanty equirements, 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 mispections, the Food and Dating may result in regulatory action. In addition, FDA may publish comply with also Cricerning your device in the Federal Register. Please note: this response to your premarks betification 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Toutman

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): K012371

Device Name: Tina-quant Transferrin ver.2

Indications For Use:

Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. 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 _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan S. Albane

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number k012371