TBIL

K981336 · Abbott Laboratories · CIG · May 1, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981336
• Device Name: TBIL
• Applicant: Abbott Laboratories
• Product Code: CIG · Clinical Chemistry
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. 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.

Device Story

Total Bilirubin assay is an in vitro diagnostic clinical chemistry test; measures bilirubin concentration in human serum or plasma samples. Principle of operation: analyte reacts with diazotised sulphanilic acid to produce acid azobilirubin; absorbance is proportional to bilirubin concentration. Used on ALCYON™ Analyzer; operated by laboratory personnel. Output is quantitative bilirubin concentration (mg/dL). Results assist clinicians in diagnosing and monitoring liver, hemolytic, and metabolic disorders. Benefits include standardized diagnostic capability for conditions like hepatitis and gall bladder block.

Clinical Evidence

Bench testing only. Method comparison study on ALCYON™ Analyzer vs. Roche Cobas Mira Plus showed correlation coefficient 0.9925, slope 0.873, Y-intercept -0.072 mg/dL. Precision studies (within-run, between-run, between-day) yielded total %CV of 4.8% (Level 1) and 5.1% (Level 2). Assay is linear up to 20.0 mg/dL with a limit of quantitation of 0.264 mg/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Uses diazotised sulphanilic acid reagent for colorimetric detection. Form factor is a liquid reagent system for use on automated chemistry analyzers. No specific materials of construction or connectivity standards provided.

Indications for Use

Indicated for the quantitative determination of total bilirubin in human serum or plasma to aid in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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® Cobas Mira® Plus Automated Chemistry System Total Bilirubin assay (K910591)

Submission Summary (Full Text)

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K981336

1 1998 MAY

# 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | April 9, 1998 |
|--------------------------------------------------|-----------------|
| Device Trade or Proprietary Name: | TBil |
| Device Common/Usual Name or Classification Name: | Total Bilirubin |
| Classification Number/Class: | 75CIG/Class II |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 149813360

#### Test Description:

Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of Total Bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the analyte in the sample reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of bilirubin in the sample.

#### Substantial Equivalence:

The Total Bilirubin assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Total Bilirubin assay (K910591).

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of total bilirubin. .
- Both assays yield similar clinical results. .

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#### Intended Use:

The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma.

## Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Total Bilirubin assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay. The correlation coefficient = 0.9925, slope = 0.873, and Y-intercept = - 0.072 mg/dL. Precision studies were conducted using the Total Bilirubin assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 4.8% and 5.1% for Level 2/Panel 112. The Total Bilirubin assay is linear up to 20.0 mg/dL. The limit of quantititation (sensitivity) of the Total Bilirubin assay is 0.264 mg/dL. These data demonstrate that the performance of the Total Bilirubin assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay.

### Conclusion:

The Total Bilirubin assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay as demonstrated by results obtained in the studies.

Total Bilirubin 510(k) April 10, 1998 TBiliE2.lwp

Section II Page 2

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

। MAY

Mark Littlefield . Section Manager, Requlatory Affairs Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038

K981336 Re : Total Bilirubin Regulatory Class: II Product Code: CIG Dated: April 9, 1998 Received: April 13, 1998

Dear Mr. Littlefield:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

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): K98/336 Device Name: Total Bilirubin

Indications For Use:

The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. 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.

> (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 1 Over-The-Counter Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)