(34 days)
K912024/A
K912024/A
No
The device description details a chemical reaction and absorbance measurement for bilirubin quantification, with no mention of AI or ML terms or concepts.
No
The text describes a device for measuring serum bilirubin concentration, which is a diagnostic test, not a therapeutic treatment.
Yes
The device measures serum bilirubin, which is explicitly stated as a "screening test for liver functions," indicating its use in diagnosing or screening for health conditions.
No
The device description clearly outlines a chemical reaction involving a sample, reagent, detergent, and vanadate, followed by absorbance measurements. This indicates a physical, laboratory-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Serum bilirubin measurement is widely used as a screening test for liver functions." This clearly indicates the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes (screening for liver functions).
- Device Description: The description details a chemical reaction that occurs with a sample (serum) and reagents to measure a substance (bilirubin) within that sample. This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance studies comparing the device to a predicate assay and providing metrics like correlation coefficient and linearity further supports its classification as an IVD, as these are standard requirements for demonstrating the analytical performance of such devices.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease or for the assessment of health.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, total bilirubin in the sample is This causes the absorbance of yellow, oxidized to biliverdin. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 mg/dL. The Wako Total Bilirubin V assay is linear to 40 mg/dL.
Key Metrics
Correlation coefficient of 0.997; regression equation y=1.003x + 0.09; minimum detectable level of 0.03 mg/dL; linear to 40 mg/dL.
Predicate Device(s)
K912024/A
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1110 Bilirubin (total or direct) test system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "Wako" in white text on a black background. The font is bold and sans-serif. The letters are closely spaced together, creating a compact and easily readable logo. The overall design is simple and modern.
510(k) Summary of Safety and Effectiveness
APR 2 1 1997
Serum bilirubin measurement is widely used as a screening test for liver functions. The methods most widely used for determination of bilirubin oxidase enzymatic method4). 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 substances, and is convenient ready-to-use liquid type serum reagent5).
When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, total bilirubin in the sample is This causes the absorbance of yellow, oxidized to biliverdin. 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 mg/dL. The Wako Total Bilirubin V assay is linear to 40 mg/dL.
References
- Malloy H.T., Evelyn K.L. The determination of bilirubin with 1. the photoelectric colorimetry. J.Biol.Chem.,199: 481-490, (1937).
- Jendrassik Cleghorn R.A. Photometrische 2. L. . bilirubinbestimmung. Biochem. Z., 289: 1-14, (1937).
- Michaelsson M. Bilirubin determination in serum and urine. 3. Scand. J.Clin.Lab.Invest.,12(Suppl 56): 1-80, (1937).
- Murao S.,Tanaka N. A new enzyme "bilirubin oxidase" produced 4 . by Myrothecium varrucaria MT-1 Agric.Biol.Chem. 45: 2383-2384, (1981).
- Tokuda K. and Tanimoto K. New method of measuring serum క్. bilirubin using vanadic acid. Jpn.Clin.Chem., 22(2), 116-122 (1993).