UBAS

K993941 · Marukin Diagnostics · KWX · Mar 2, 2000 · Clinical Chemistry

Device Facts

• Record ID: K993941
• Device Name: UBAS
• Applicant: Marukin Diagnostics
• Product Code: KWX · Clinical Chemistry
• Decision Date: Mar 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1187
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Assay kit for colorimetric determination of urinary total bile acid sulfate (UBAS). Used in clinical laboratory settings by trained personnel. Input: urine sample. Process: chemical assay reaction resulting in colorimetric change proportional to UBAS concentration. Output: quantitative measurement of UBAS. Assists clinicians in assessing bile acid metabolism and liver function.

Technological Characteristics

Colorimetric assay kit for quantitative determination of urinary total bile acid sulfate. In vitro diagnostic reagent system.

Indications for Use

Indicated for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.

Regulatory Classification

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.

Submission Summary (Full Text)

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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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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, [phone]. Additionally, the quest [phone]. 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 [phone] or [phone] 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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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)