TOTAL BILIRUBIN REAGENT SET

K040391 · Pointe Scientific, Inc., · CIG · Jun 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040391
• Device Name: TOTAL BILIRUBIN REAGENT SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: CIG · Clinical Chemistry
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This product is to be used in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.

Device Story

Pointe Scientific Direct and Total Bilirubin assays are quantitative colorimetric reagents for use on Hitachi clinical chemistry analyzers. Input: human serum samples. Principle: bilirubin couples with diazonium salt (DPD) in acidic medium to form azobilirubin; measured spectrophotometrically. Output: bilirubin concentration (mg/dL). Used in diagnostic laboratories by qualified technologists. Results assist clinicians in assessing liver function and conditions like hemolytic or obstructive jaundice.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of in vitro diagnostic test systems.

Technological Characteristics

Quantitative colorimetric assay. Reagents: liquid, ready-to-use, containing acid buffers and DPD stabilizers. Sensing: spectrophotometric measurement of azobilirubin. Form factor: reagent kits for automated clinical chemistry analyzers (Hitachi 704, 717, 747, 911, 912).

Indications for Use

Indicated for the quantitative determination of direct and total bilirubin in human serum to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice in a clinical laboratory setting.

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.

Predicate Devices

• Roche Total Bilirubin Reagent (K910591)
• Roche Direct Bilirubin Reagent (K910593)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 2 2004

Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, MI 48146

k040391 Re:

Ko 16571
Trade/Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: May 6, 2004 Received: May 19, 2004

Dear Mr. Jamison:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 75 the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1970, as easonance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costinetter (110) that to the vice, subject to the general controls provisions of the Act. The r ou may, increrere, mains 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 (PMA), it your device is classified divinal controls. Existing major regulations affecting your device n may be subject to sach about Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devilsed that I Drivision that your device complies with other requirements of the Act that I Dr has made a and regulations administered by other Federal agencies. You must or any I catal statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premated predicated. " ceresults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire operation and advertising of your device, please contact the Office of or questions on the promote and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oount outer generers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, U.S. Div.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040391 - - - -

Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin

Indications For Use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory t mo proguets, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation an

510(k)

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