BILIRUBIN-SL (TOTAL) ASSAY

K974874 · Diagnostic Chemicals, Ltd. (Usa) · CIG · Feb 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974874
• Device Name: BILIRUBIN-SL (TOTAL) ASSAY
• Applicant: Diagnostic Chemicals, Ltd. (Usa)
• Product Code: CIG · Clinical Chemistry
• Decision Date: Feb 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

For the quantitative determination of Total Bilirubin in serum. For IN VITRO diagnostic use.

Device Story

Total Bilirubin-SL Assay is an in vitro diagnostic reagent kit for quantitative measurement of total bilirubin in serum. Principle of operation: chemical reaction where 2,4-dichlorophenyl diazonium salt reacts with bilirubin in the presence of a surfactant to form a colored azo-bilirubin compound. The intensity of the color is proportional to the bilirubin concentration. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing and monitoring hemolytic processes, liver disease, and biliary tract disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent; chemical assay based on diazo reaction; utilizes 2,4-dichlorophenyl diazonium salt and surfactant; manual or automated spectrophotometric measurement.

Indications for Use

Indicated for the quantitative determination of Total Bilirubin in serum for in vitro diagnostic use. Used to assess hemolytic processes, liver disease, or biliary tract disorders.

Regulatory Classification

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.

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 2 1998

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator DIAGNOSTIC CHEMICALS LIMITED 16 First Street West Royalty Industrial Park Charlottetown, PE CANADA C1E 1BO

Re: K974874 Trade Name: Bilirubin-SL (TOTAL) Assay Regulatory Class: II Product Code: CIG 75 Dated: December 19, 1997 Received: December 29, 1997

Dear Ms. Callbeck:

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 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 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 In addition, FDA may publish further regulatory action. 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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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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K97 4874 510(k) Number (if known): ___

Device Name: Total Bilirubin-SL Assay

## Indications for Use:

For the quantitative determination of Total Bilirubin in serum. For IN VITRO diagnostic use. Bilirubin is a bile pigment normally found in serum as a result of red cell destruction. It is a product of hemoglobin breakdown by the reticuloendothetial system and exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it becomes conjugated (direct) with glucuronic acid and excreted.

The elevation of total serum bilirubin may occur due to hemolytic processes, liver disease, or a disorder of the biliary tract.

Traditional methods of measuring bilirubin are based on the reaction of bilirubin with a diazo reagent to form the colored compound: azo-bilirubin. The diazo reaction can be accelerated by the addition of various chemicals. For example, Malloy-Evelyn (1) used ethanol, Jendrassik-Grof (2) used caffeine, and Walters-Gerarde (3) used DMSO. Modifications of these methods included the addition of surfactants as solubilizing agents (4).

In this method, a 2,4-dichlorophenyl diazonium salt is used as the diazo reagent and the reaction is facilitated by the use of a surfactant.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Berlaust (for A. Montgomery)
(Division Sign-Off)

**Prescription Use**
(Per 21 CFR 801.109

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)