WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR

K984122 · Wako Chemicals USA, Inc. · JQF · Jan 20, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984122
• Device Name: WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JQF · Clinical Chemistry
• Decision Date: Jan 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

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

Device Story

Wako L-type UIBC is an in vitro diagnostic assay for serum iron measurement. Input: serum sample. Principle: sample mixed with buffer containing known excess iron; unsaturated transferrin binds iron; remaining unbound iron assayed via color development using ascorbic acid and bathophenanthroline disulfonic acid disodium salt. Output: quantitative UIBC value calculated by decrement of iron in buffer. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing iron deficiency anemia, hemochromatosis, chronic inflammatory disorders, and malignancies.

Clinical Evidence

Bench testing only. Precision studies performed to evaluate day-to-day performance. Minimum detectable level estimated at 1.8 mg/dL. Assay demonstrated linearity up to 600 ug/dL.

Technological Characteristics

In vitro diagnostic assay; utilizes bathophenanthroline as a chromogen; colorimetric detection method; liquid reagent format; standalone diagnostic test.

Indications for Use

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

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Predicate Devices

• Wako UIBC manual test

Submission Summary (Full Text)

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P. 02/10

1984122

JAN 2 0 1999

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

## 510(k) Summary of Safety and Effectiveness

The Wako L-type UIBC 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 iron, bound to transferrin. Serum transferrin has considerable reserve iron binding capacity, which is called the serum unsataturated iron binding capacity (UIBC), because normally about one third of the iron binding sites of transferrin are occupied by iron. Measurement of serum iron concentration, UIBC and total iron binding capacity (TIBC) are 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 UIBC and TIBC.12 The Wako Letype UIBC is a method utilizing bathophenanthroline as a chromogen.

When a sample is mixed with the Buffer containing a known excess amount of iron, unsaturated transferrin in serum quantitatively associates with iron in the Buffer and is converted to a saturated state. The portion of iron which remains unassociated is assayed through color development with ascorbic acid and bathophenanthroline disulfonic acid disdoium salt. The unsaturated transferrin concentration in the sample can be determiend by calculating the decrement of iron in the Buffer.

The safety and effectiveness of the Wako L-type UIBC assay is demonstrated by its substantial equivalency to the Wako UIBC manual 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 1.8 mg/dL. The Wako L-type UIBC assay has determined to be linear to 600 ug/dL.

Kura Mallin

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, 2nd ed., 1. Saunders, Philadelphia, 1994.

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Public Health Service

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JAN 2 0 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

Re: K984122 Trade Name: Wako L-type UIBC and Wako UIBC Calibrator Regulatory Class: I Product Code: JQF 118 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 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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510(k) NUMBER (IF KNOWN): _ K98 4122 L-type UIBC, Wako VIBC Calibrator DEVICE NAME: INDICATIONS FOR USE:

capacity measurements oed in and treatmen

Sean Cooper
Division Sign-Off

ivision Sign-Off ) Number

(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)