DIRECT BILIRUBIN REAGENT

K011972 · Intersect Systems, Inc. · CIG · Aug 27, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011972
• Device Name: DIRECT BILIRUBIN REAGENT
• Applicant: Intersect Systems, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

Bilirubin is an organic compound formed during the normal and abnormal breakdown of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.

Device Story

Direct Bilirubin Reagent is an in vitro diagnostic chemical reagent system; used for quantitative measurement of direct bilirubin in serum or plasma samples. Operates via chemical reaction principles typical of clinical chemistry analyzers; provides numerical concentration values. Used in clinical laboratory settings by trained laboratory personnel. Results are interpreted by physicians to assess liver function, hemolytic conditions, and metabolic disorders; aids in clinical decision-making regarding diagnosis and treatment of conditions like hepatitis or biliary obstruction.

Clinical Evidence

No clinical data provided; device is a chemical reagent system for in vitro diagnostic use.

Technological Characteristics

In vitro diagnostic chemical reagent; quantitative colorimetric or spectrophotometric assay for direct bilirubin; intended for use on clinical chemistry analyzers; regulated under 21 CFR 862.1110.

Indications for Use

Indicated for use as an in vitro diagnostic tool for the quantitative determination of direct bilirubin in serum or plasma to aid in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.

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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AUG 2 7 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark E. Legaz, Ph.D., DABCC President Intersect Systems, Inc. P.O. Box 2219 Longview, WA 98632

Re: K011972 Trade/Device Name: Direct Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulatory Class: II Product Code: CIG Dated: June 12, 2001 Received: June 25, 2001

Dear Dr. Legaz:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 nouncation. The I Dri imamig 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 1 If you desire specific advice for your actives), please contact the Office of Compliance at additionally 807.10 for in vito allegitestions on the promotion and advertising of your device, [phone]. Additionally, Ice quice at [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 Information on your responsionates and er Assistance at its toll-free number [phone] or Manufacturers International and Somber 11ttp://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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## Indication for Use

Trade Name of the Device: Direct Bilirubin Reagent

510(k) Number:

Classification Name; Number:

Bilirubin (total or direct) Test System; 21 CFR §862.1110

Indications for Use

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prescription use

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510(k) Number