(52 days)
970985
Not Found
No
The device description details a chemical oxidation method for measuring bilirubin, with no mention of AI or ML algorithms. The performance studies focus on substantial equivalency to a predicate device using a similar chemical method.
No.
The device is a diagnostic reagent used to measure total bilirubin levels, which is for screening and diagnosis, not for therapy.
Yes
The device measures total bilirubin concentration, which is useful in the screening of liver function disorders or the diagnosis of jaundice, indicating its use in diagnosing medical conditions.
No
The device description clearly states it is a "liquid type reagent" and describes a chemical oxidation method, indicating it is a laboratory assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "Indication of serum and plasma bilirubin," which is a measurement performed on biological samples in vitro (outside the body). This measurement is used for "screening of liver function disorders or in the diagnosis of jaundice," which are medical conditions.
- Device Description: The description details a chemical method using reagents to analyze a sample (serum and plasma). This is a typical characteristic of an in vitro diagnostic test.
- Predicate Device: The mention of a predicate device (K970985; Wako Total Bilirubin assay) which is also an IVD, further supports that this device falls under the IVD category.
The device performs a test on a biological sample (serum and plasma) to provide information for the diagnosis or screening of a medical condition (liver function disorders, jaundice). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
Product codes (comma separated list FDA assigned to the subject device)
JFM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
970985
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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
Telephone (804) 271-7677 Facsimile (804) 271-7791 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
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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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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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