(52 days)
970986
970986
No
The device description details a chemical reaction and absorbance measurement for bilirubin determination, with no mention of AI or ML algorithms. The performance study relies on substantial equivalence to a predicate device, not on AI/ML performance metrics.
No
This device is used for the diagnosis of liver function disorders and jaundaice, which falls under the category of in vitro diagnostic devices, not therapeutic devices. Therapeutic devices are used for treating patients.
Yes
The document states that the determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice, indicating the device is used for diagnostic purposes.
No
The device description clearly describes a chemical assay involving reagents and sample mixing, which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Determination of serum and plasma bilirubin," which is a measurement performed on biological samples in vitro (outside the body). This is a key characteristic of IVDs.
- Device Description: The description details a chemical reaction involving a sample and a reagent to measure a substance (bilirubin) within the sample. This process is performed in vitro.
- Performance Studies: The performance study compares the device to a predicate device that is also an IVD (indicated by the 510(k) number and the name "Direct Bilirubin assay"). This further confirms its classification as an IVD.
N/A
Intended Use / Indications for Use
Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
Product codes
LFM
Device Description
When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct 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
Not Found
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 Direct Bilirubin V assay is demonstrated by its substantial equivalency to our previous Direct Billrubin assay (510(K) # 970986). The previously marketed device (510k# 970986) 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) # 970986.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
970986
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.
DEC 3 0 2005
K053/32
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 123 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 Direct 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, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct 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 Direct Bilirubin V assay is demonstrated by its substantial equivalency to our previous Direct Billrubin assay (510(K) # 970986). The previously marketed device (510k# 970986) 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) # 970986.
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 Mvrothecium varrucaria MT-1. Agric. Biol. Chem. 45: 2383-2384. (1981).
(5) Tokuda K. and Tanimoto K. New method of measuring serum billrubin 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).
Lori Creasy
November 7, 2005 Regulatory Affairs Specialist Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEC 3 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals, USA Inc. 1600 Bellwood Road Richmond VA, 23237
Re: K053132
Trade/Device Name: Wako Direct Bilirubin V Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: LFM 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).
2
Page 2 -
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
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
3
| 510(k) Number (if known): | ||
|---|---|---|
| --------------------------- | -- | -- |
Device Name: Wako Direct Bilirubin V
Indications For Use:
Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
CAC
Division Sign Off
Office of Diagnostic Device
Evaluation and Safety
10(k) K05 3132
Page 1 of