WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

K053131 · Wako Chemicals USA, Inc. · JFM · Dec 30, 2005 · Clinical Chemistry

Device Facts

• Record ID: K053131
• Device Name: WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JFM · Clinical Chemistry
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

Device Story

Wako Total Bilirubin V is an in vitro diagnostic reagent for measuring total bilirubin in serum or plasma. The device utilizes a chemical oxidation method where a sample is mixed with a reagent containing detergent and vanadate at approximately pH 3. This process oxidizes total bilirubin to biliverdin, causing a decrease in yellow absorbance. The concentration is determined by measuring absorbance before and after vanadate oxidation. The assay is intended for use in clinical laboratory settings to assist healthcare providers in screening for liver function disorders or diagnosing jaundice. It offers improved stability and reduced interference from coexistent serum substances compared to traditional diazo coupling or enzymatic methods.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance and comparison to the predicate device.

Technological Characteristics

Dual-reagent enzymatic colorimetric system. Sensing principle: vanadate oxidation of bilirubin to biliverdin measured via 451 nm absorbance. Reportable range: 0.1-40 mg/dL. Storage: 2-35°C. Compatible with ADVIA 1650 analyzer. Matrix: serum and plasma.

Indications for Use

Indicated for screening liver function disorders or diagnosing jaundice in patients requiring serum or plasma bilirubin testing. Not tested in neonates. Prescription use only.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• Wako Total Bilirubin V (k970985)

Submission Summary (Full Text)

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**DEC 30 2005**

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

## 510(K) Summary of Safety and Effectiveness

Serum and plasma measurement is widely used as a screening test for liver functions. The methods most widely used for determination of serum bilirubin are the diazo coupling method 1.2.3 and the bilirubin oxidase enzymatic method . However, these methods have disadvantages such as interference by coexistent serum substances unsatisfactory stability of reagents after preparation. Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidating agent, shows good correlation with conventional methods, practically no interference by coexistent serum and plasma substances, and is convenient ready-to-use liquid type reagent®.

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

The safety and effectiveness of the Wako Total Bilirubin V assay is demonstrated by its substantial equivalency to our previous Total Bilirubin assay (510(K) # 970985). The previously marketed device (510k# 970985) was marketed for serum samples and this submission adds the use of plasma as a sample. There are no changes to performance claims already established in 510(k) # 970985.

## References:

(1) Malloy H. T., Evelyn K. L. The determination of bilirubin with the photoelectric colorimetry. J. Biol. Chem., 199: 481-490, (1937).

(2) Jendrassik L., Cleghorn R. A. Photometrische bilirubinbestimmung. Biochem. Z., 289: 1-14, (1937).

(3) Michaelsson M. Bilirubin determination in serum and urine. Scand. J. Clin. Lab. Invest., 12 (Suppl 56): 1-80. (1937).

(4) Murao S., Tanaka N. A new enzyme "bilirubin oxidase" produced by Myrothecium varrucaria MT-1. Agric. Biol. Chem. 45: 2383-2384, (1981).

(5) Tokuda K. and Tanimoto K. New method of measuring serum bilirubin using vanadic acid. Jpn. J. Clin. Chem., 22 (2), 116-122 (1993).

(6) Carl A.Burtis, Edward R. Ashwood, TIETZ TEXTBOOK of Clinical Chemistry, second edition, P1468 (SAUNDERS).

loe Creasy

Lori Creasy November 7, 2005 Regulatory Affairs Specialist Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming a stylized shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 3 0 2005

Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals, USA Inc. 1600 Bellwood Road Richmond VA, 23237

Re: k053131

> Trade/Device Name: Wako Total Bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: JFM Dated: November 7, 2005 Received: November 9, 2005

Dear Ms. Creasy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE:

510(k) Number (if known):

Device Name: Wako Total Bilirubin V

Indications For Use:

Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

SIU(k).

Office of In Vi. . Diagnostic Device Evaluation and Safety 113333

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