WAKO TOTAL BILIRUBIN V

K970985 · Wako Chemicals USA, Inc. · JFM · Apr 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970985
• Device Name: WAKO TOTAL BILIRUBIN V
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JFM · Clinical Chemistry
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

Serum bilirubin measurement is widely used as a screening test for liver functions.

Device Story

In vitro diagnostic reagent for total bilirubin measurement in serum; utilizes chemical oxidation method with vanadate as oxidizing agent at pH 3; bilirubin oxidized to biliverdin causing decrease in yellow absorbance; absorbance measured before and after oxidation to determine concentration; used in clinical laboratory settings by trained personnel; provides quantitative results to assist clinicians in assessing liver function; ready-to-use liquid reagent format.

Clinical Evidence

Bench testing only. Comparison study against predicate assay using serum samples yielded correlation coefficient of 0.997 and regression equation y=1.003x + 0.09. Precision studies confirm day-to-day reproducibility. Analytical sensitivity (minimum detectable level) is 0.03 mg/dL; linearity range up to 40 mg/dL.

Technological Characteristics

Chemical oxidation assay using vanadate as oxidizing agent and detergent at pH 3. Liquid reagent format. Photometric measurement of absorbance decrease. No specific materials or software algorithms described.

Indications for Use

Indicated for the quantitative determination of total bilirubin in human serum as a screening test for liver function.

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

• Total Bilirubin assay (K912024/A)

Reference Devices

• Malloy H.T., Evelyn K.L. J.Biol.Chem. 1937
• Jendrassik L., Cleghorn R.A. Biochem.Z. 1937
• Michaelsson M. Scand. J.Clin.Lab.Invest. 1960
• Murao S., Tanaka N. Agric.Biol.Chem. 1981
• Tokuda K. and Tanimoto K. Jpn.Clin.Chem. 1993

Submission Summary (Full Text)

{0}

Wako

Wako Chemicals USA, Inc.

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

Telephone [phone] Telex 293208 WAKO UR(RCA) Facsimile [phone]

K970985

APR 21 1997

# 510(k) Summary of Safety and Effectiveness

Serum bilirubin 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 $^{4)}$. 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 oxidizing agent, shows good correlation with conventional methods, practically no interference by coexistent serum substances, and is convenient ready-to-use liquid type reagent $^{5)}$.

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, 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 absorbance before and after the vanadate oxidation.

The safety and effectiveness of the Wako Bilirubin V assay is demonstrated by its substantial equivalency to our previous Total Bilirubin assay (510(k)#K912024/A). Both test systems are used to measure total bilirubin is serum. In comparison studies against the predicate assay, a correlation coefficient of 0.997 and a regression equation $y=1.003x + 0.09$ was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is $0.03 \, \text{mg/dL}$. The Wako Total Bilirubin V assay is linear to $40 \, \text{mg/dL}$.

# 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 varucaria 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.Clin.Chem., 22(2), 116-122 (1993).