WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR

K984119 · Wako Chemicals USA, Inc. · CFM · Jan 15, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984119
• Device Name: WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: CFM · Clinical Chemistry
• Decision Date: Jan 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Intended Use

Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis, and chronic renal disease.

Device Story

Wako L-type Fe is an in vitro diagnostic assay for quantitative serum iron measurement. Input: serum sample. Principle: surfactant denatures serum protein to release transferrin-bound iron; L-ascorbate reduces Fe3+ to Fe2+; Fe2+ forms a red chelate with bathophenanthroline disulfonic acid disodium salt. Output: absorbance of red chelate solution, proportional to iron concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing iron-related disorders.

Clinical Evidence

Bench testing only. Precision studies demonstrated acceptable day-to-day performance. The assay is linear up to 1000 mg/dL with a minimum detectable level of 1.2 mg/dL.

Technological Characteristics

In vitro diagnostic chemical assay. Reagents include buffer with surfactant, L-ascorbate, and bathophenanthroline disulfonic acid disodium salt. Measurement principle: colorimetric spectrophotometry (absorbance of red chelate).

Indications for Use

Indicated for the quantitative determination of iron in serum to aid in the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Predicate Devices

• Wako Fe B test

Submission Summary (Full Text)

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JAN 1 5 1999

1984119

Wako Chemicals USA. Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A

## 510(k) Summary of Safety and Effectiveness

The Wako L-type Fe test is an in vitro diagnostic assay for the quantitative determination of iron in serum.

Approximately two thirds of iron in the body is in hemoglobin of red blood corpuscles (RBCs) and the rest is in liver, spleen, bone marrow and other tissues as stored in iron. Numerous cellular enzymes and coenzymes require iron, such as peroxidases and cytochromes. Transport of iron from one organ to another is accomplished by serum iton, bound to transferrin. Measurement of serum iron concentration is largely of use in the diagnosis of iron deficiency anemia, hemochromatosis, chronic inflammatory disorders and malignancies. There are several methods used for the measurement of iron concentration. The Wako L-type Fe is a method utilizing bathophenanthroline as a chromogen.

When a sample is mixed with the Buffer, serum protein is denatured by the action of surfactant contained in the Buffer and transferrin-bound iron is liberated. All the Fe" ions released are reduced to Fe2+ by L-ascorbate and form a chelate with bathophenanthroline disulfonic acid disodium salt. The serum iron can be determined by measuring the absorbance of the red chelate solution.

The safety and effectiveness of the Wako L-type Fe assay is demonstrated by its substantial equivalency to the Wako Fe B test.

Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1.2 mg/dL. The Wako L-type Fe assay had determined to be linear to 1000 mg/dL.

Luca Mallus

Tonya Mallory, Senior Manager, Diagnostics January 12, 1999 Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

References:

- Burtis, C.A. and Ashwood, E.R .: Tietz Textbook of Clinical Chemistry, 200 ed., 1. Saunders, Philadelphia, 1994.

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Public Health Service

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JAN 1 5 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K984119 Re: Trade Name: Wako L-type Fe and Wako Fe Calibrator Regulatory Class: I Product Code: CFM 112 II Dated: November 16, 1998 Received: November 18, 1998

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 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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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 vours.

Steven Butman

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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Page 1 of 1

510(k) NUMBER (IF KNOWN): _K 984119 L-type E, prakok Calibrator DEVICE NAME: INDICATIONS FOR USE

I von measurements an used in the diagnosis and t of diseases such as in on deficiency an hemochromatosis, and chronic renal disease.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 98419

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)