(63 days)
None
Not Found
No
The 510(k) summary describes a colorimetric assay kit for chemical analysis, with no mention of AI, ML, image processing, or data analysis techniques typically associated with AI/ML.
No
The device is an assay kit for diagnostic purposes (determining UBAS levels), not for treating a condition.
Yes
The device is described as an "Assay Kit for Urinary Total Bile Acid Sulfate" intended for the "colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults." This determination of a substance in the body (UBAS) for diagnostic purposes (though not explicitly stated as such, determination of biomarkers is a key step in diagnosis) classifies it as a diagnostic device.
No
The device description clearly states "Assay Kits," which implies physical components (reagents, containers, etc.) are involved, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults." This clearly indicates that the device is used to perform a test on a biological sample (urine) in vitro (outside the body) to obtain diagnostic information.
- Device Description: The device is described as "Assay Kits for Urinary Total Bile Acid Sulfate." Assay kits are a common type of IVD used for performing specific tests on biological samples.
- Anatomical Site: The test is performed on a sample from the "Urinary" system. This is a biological sample.
The key characteristic of an IVD is that it is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The Marukin Shoyu Co., Ltd's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.
Product codes
KWX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary
Indicated Patient Age Range
children and adults
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
(a)
Identification. A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an eagle or bird-like figure with three human profiles incorporated into its design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 5 1998
Kyoto Research Laboratories .Greq Holland C/O Marukin Shoyu Co., Ltd. 3722 Ave. Sausalito Irvine, California 92606
Re : K980525 Assay Kits for Urinary Total Bile Acid Sulfate Requlatory Class: II Product Code: KWX Dated: February 9, 1998 Received: February 11, 1998
Dear Mr. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Marukin Shoyu Co., Ltd's Assay Kits for Urinary Total Bile Acid Sulfate
Indications For Use:
The Marukin Shoyu Co., Ltd's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 0 A (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 1 Over-The-Counter Use_ Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
February 9, 1998
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