WAKO BILIRUBIN CALIBRATOR

K993219 · Wako Chemicals USA, Inc. · JIS · Nov 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993219
• Device Name: WAKO BILIRUBIN CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct bilirubin methodology for the determination of total and direct bilirubin in serum.

Device Story

Wako Bilirubin Calibrator serves as calibration material for total and direct bilirubin assays in human serum; used in clinical laboratory settings to establish reference points for quantitative bilirubin determination; ensures accuracy of diagnostic testing; performance validated via correlation studies against predicate bilirubin standards.

Clinical Evidence

Bench testing only. Correlation studies comparing the subject device to the predicate bilirubin standard yielded a correlation coefficient of 1.000 (y=0.99x-0.0027) for total bilirubin and 0.9999 (y=0.97x-0.0031) for direct bilirubin.

Technological Characteristics

In vitro diagnostic calibration material for serum bilirubin assays. Liquid-based calibrator formulation. No specific materials of construction, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a calibration material to establish reference points for the determination of total and direct bilirubin values in human serum specimens.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Wako Bilirubin Standard (K993219)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date November 9, 1999. The month is abbreviated to NOV. The day is the number 9. The year is 1999.

Image /page/0/Picture/1 description: The image shows the word "Wako" in bold, white letters against a black background. The text is simple and clear, with a modern sans-serif font. The word is positioned in the upper-left corner of the black square.

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

## /<993219

## 510(k) Summary of Safety and Effectiveness

The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct The Wako Billitoom Canbrator is Gesigned to overhodology for the determination of total and direct bilirubin in serum.

The safety and effectiveness of the Wako Bilirubin Calibrator is demonstrated by its The Saley and crised of the Wako Bilirubin Standard. Both calibration material are substantial equivalency to me Wallo Dhilinobin in serum. In comparison studies against the predicate bilirubin standard, a correlation coefficient of 1.000 and a regression equation of y =0.99x -.0027 was obtained for total bilirubin and a correlation coefficient of 0.9999 and a regression equation of y=0.97x -0.0031 for direct bilrubin.

Luiza Valluz

September 22, 1999 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes suggesting a head, body, and legs. The symbol is rendered in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 9 1999

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

Re: K993219

Trade Name: Wako Bilirubin Calibrator Regulatory Class: II Product Code: JIS Dated: September 22, 1999 Received: September 27, 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 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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K993219 510(k) umber (if known): wa Ko irubin Device Name: alibrator

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