(104 days)
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Not Found
No
The summary describes a colorimetric assay kit for chemical analysis, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is an assay kit intended for the determination of urinary total bile acid sulfate, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" states the kit is "intended for the colorimetric determination of urinary total bile acid sulfate (UBAS)..." This determination assists in the identification or monitoring of a disease or condition, which is the definition of a diagnostic device.
No
The device description clearly indicates it is an "Assay Kit," which implies physical components (reagents, tubes, etc.) for a colorimetric determination, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults." This involves testing a sample (urine) taken from the human body to provide information about a physiological state (levels of UBAS).
- Device Description: The device is described as an "Assay Kit," which is a common format for IVD products used to perform specific tests on biological samples.
- Anatomical Site: The test is performed on a sample from the "Urinary" system, which is a biological sample source.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The Marukin Diagnostic'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
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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
Urinary
Indicated Patient Age Range
children and adults
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines or strokes, arranged in a way that suggests movement or flow.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 2 2000
Mr. Greg Holland Consultant Marukin Diagnostics 2363 Tripaldi Way Hayward, California 94545
Re: K993941
Trade Name: Assay kit for Urinary Total Bile Acid Sulfate Regulatory Class: II Product Code: KWX Dated: January 13, 2000 Received: January 14, 2000
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
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Page 2
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 noutication. The PD7 maing of succion 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 If you desire specific advice for your do rios on val, please contact the Office of Compliance at additionally 607.10 for in this diagnostions on the promotion and advertising of your device, (301) 594-4388. Additionally, the quest (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountation on your responsibility and its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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 3 Page_ 1_of__1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Assay Kit for Urinary Total Bile Acid Sulfate_
Indications For Use:
The Marukin Diagnostic'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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993941
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)