WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR

K993162 · Wako Chemicals USA, Inc. · DDG · Nov 12, 1999 · Immunology

Device Facts

• Record ID: K993162
• Device Name: WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: DDG · Immunology
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

Measurement of transferrin levels aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Device Story

Wako Transferrin test is an in vitro diagnostic assay for quantitative determination of transferrin in serum; used in clinical laboratories. Input: patient serum sample. Principle: turbidimetric immunoassay; sample mixed with buffer and anti-human transferrin antiserum; transferrin binds to antibodies forming insoluble aggregates; turbidity increases proportionally to transferrin concentration. Output: optical measurement of turbidity correlated to transferrin levels. Healthcare providers use results for differential diagnosis of anemia and monitoring treatment. Benefits: provides objective data for assessing iron-carrying protein levels.

Clinical Evidence

Bench testing only. Comparison study against predicate assay demonstrated a correlation coefficient of 0.988 and regression equation y = 0.975x + 0.41. Precision studies indicate acceptable day-to-day performance. Minimum detectable level is 4.7 mg/dL.

Technological Characteristics

In vitro diagnostic turbidimetric immunoassay. Utilizes anti-human transferrin antibodies. Measures optical turbidity proportional to transferrin concentration. Standalone assay format.

Indications for Use

Indicated for the quantitative determination of transferrin in serum to aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as 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

• Beckman Transferrin product

Submission Summary (Full Text)

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K993162

# 510(k) Summary of Safety and Effectiveness

The Wako Transferrin test is an in vitro diagnostic assay for the quantitative determination of transferrin in serum.

#### Summary:

Wako Chemicals USA. Inc.

1600 Bellwood Road, Richmond, VA 23237 U.S.A.

Transferrin is the major iron-carrying protein in blood plasma. It is mainly synthesized in the liver. It is a glycoprotein, which has a molecular weight of 80kDa. The molecule is divided in two domains, each conatining one metal-binding site. Iron is the most important metal bound by transferrin in vivo. Clinical evaluation of transferrin levels is useful for the differential diagnosis of anemia and for monitoring its treatment. Assay methods for measuring transferrin have been developed, such as immunochemical methods, nephelometry, radial immunodiffusion(RID), turbidimetric immunossay. Wako transferrin test utilizes turbidimetric immunoassay .

#### Principle:

When the sample is mixed with Buffer and Antiserum, transferrin in the sample combines specifically with anti-human transferrin antibodies in the Antiserum to vield an insoluable aggregate that causes increased turbidity. The degree of turbidity call an measured optically and is proportional to the amount of transferrin in the sample.

The safety and effectiveness of the Wako Transferrin assay is demonstrated by its substantial equivalency to the Beckman Transferrin product. Both test systems are used complete transferrin in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.988 and a regression equation of y =0.975x + 0.41 was obtained. Precision studies indicate acceptable values can be obtained on a do to day basis. The minimum detectable level of this method is 4.7 mg/dL.

#### References

Jong, G, et al .: The Biology of Transferrin. Clin. Chim. Acta, 190:1-46, 1990. 1.

September 17, 1999 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

> Telephone [phone] Facsimile [phone]

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### NOV 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tonya Mallory Senior Manager, Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237

Kc: K993162

Trade Name: Wako Transferrin, Transferrin Calibrator Regulatory Class: II Product Codc: DDG Dated: September 17, 1999 Received: September 22, 1999

Dear Ms. Mallory:

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 predically of the indications for the indications for use prior to May 28, 1976, the enactment date of the Medical In mierstate comments, 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) of Class III
affecting your designed many be subject to such additional controls. Existing major regulat 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 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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K993162 510(k) Number (if known): _ Transfirin assay A/AKU Device Name: Calibrator Transferrin

## Indications For Use:

Measurement of transferrin levels aid
in the diagnosis of malnutrition, acute
inflammation, infection, and red blood
cell disorders, such as iron deficiency
anemia.

(PLRASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices K993162
510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)