OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

K080435 · Olympus Life Science Research Europa GmbH (Europa) · CIG · Sep 5, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080435
• Device Name: OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
• Applicant: Olympus Life Science Research Europa GmbH (Europa)
• Product Code: CIG · Clinical Chemistry
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use.

Device Story

Olympus Direct Bilirubin Reagent (OSR6X181) is an in vitro diagnostic reagent for use on Olympus clinical chemistry analyzers. It measures direct bilirubin levels in human serum samples. The reagent facilitates quantitative determination of bilirubin, which is produced during red blood cell destruction. Results are used by clinicians to diagnose and monitor liver, hemolytic, and metabolic conditions, including hepatitis and gallbladder obstruction. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing: precision (CLSI EP5-A2), linearity (0.05–10 mg/dL), limit of quantitation, and analytical specificity (interference testing for hemoglobin and intralipid). Method comparison study (n=50-73) against predicate device showed high correlation (r > 0.99).

Technological Characteristics

Quantitative colorimetric assay. Reagents: 3,5-Dichlorophenyl Diazonium (BF)₄ and Hydrochloric acid. Measurement: Bichromatic photometry at 540/600 nm. Form factor: Liquid reagents for automated Olympus AU series analyzers. Stability: 30 days on-board. Standards: CLSI EP9-A2, EP5-A2, C-28.

Indications for Use

Indicated for quantitative determination of Direct Bilirubin in human serum to aid in diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders (e.g., hepatitis, gall bladder block). For in vitro diagnostic use.

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

• Olympus Direct Bilirubin Reagent (k924963)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract eagle design.

Public Health Service

5 2008

SEP

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Olympus Life Science Research Europa, GmbH c/o Olympus America. Inc. Ms. Stephanie Donnelly Regulatory, Clinical & Scientific Affairs Project Manager 3131 West Royal Lane Irving, TX 75063

Re: k080435

> Trade/Device Name: The Olympus Direct Bilirubin Reagent (OSR6X181) Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: August 26, 2008 Received: August 28, 2008

Dear Ms. Donnelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practicc 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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## Indication for Use

510(k) Number (if known):

Device Name: The Olympus Direct Bilirubin Reagent (OSR6X181).

Indication For Use: System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers.

Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

For in vitro diagnostic use.

Prescription Use ___ V_ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080435