DIRECT BILIRUBIN

K022180 · Abbott Laboratories · CIG · Sep 6, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022180
• Device Name: DIRECT BILIRUBIN
• Applicant: Abbott Laboratories
• Product Code: CIG · Clinical Chemistry
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma. Measurement of direct 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

Direct Bilirubin is an in vitro diagnostic assay for quantitative determination of direct bilirubin in human serum and plasma. Principle: direct (conjugated) bilirubin couples with diazonium salt in presence of sulfamic acid to form colored azobilirubin. Device measures increase in absorbance at 548 nm, which is proportional to direct bilirubin concentration. Used on AEROSET and ARCHITECT c8000 systems in clinical laboratory settings. Healthcare providers use results to diagnose and monitor liver, hemolytic, and metabolic disorders. Benefits include accurate assessment of bilirubin levels for clinical decision-making regarding patient liver and metabolic health.

Clinical Evidence

Bench testing only. Comparative performance studies conducted on AEROSET and ARCHITECT c8000 systems against the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer. Correlation coefficients were 0.995 (AEROSET) and 0.996 (ARCHITECT c8000). Precision studies (within-run, between-run, between-day) showed total %CVs ranging from 0.7% to 4.1% across four control levels. Limit of quantitation is 0.04 mg/dL.

Technological Characteristics

In vitro colorimetric assay. Principle: diazonium salt coupling in presence of sulfamic acid. Detection: absorbance at 548 nm. Assay range: 0.1 to 16.9 mg/dL. Sensitivity (LOQ): 0.04 mg/dL. Compatible with human serum and plasma. Designed for use on automated clinical chemistry analyzers (AEROSET and ARCHITECT c8000).

Indications for Use

Indicated for the quantitative determination of direct bilirubin in human serum and 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 Direct Bilirubin assay on the Hitachi 717 Analyzer

Submission Summary (Full Text)

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6 2002 SEP

# 510(k) Summary

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

Contact Person Michele Smith-Waheed Senior Regulatory Specialist MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | June 28, 2002 |
|--------------------------------------------------|------------------|
| Device Trade or Proprietary Name: | Direct Bilirubin |
| Device Common/Usual Name or Classification Name: | Direct Bilirubin |
| Classification Number/Class: | CIG, 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: KO 22180

### Test Description:

Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum and plasma. Direct (conjugated) bilirubin couples with a diazonium salt in the presence of sulfamic acid to form the colored compound, azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is proportional to the direct bilirubin concentration.

Section II Page 1

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## Substantial Equivalence:

The Direct Bilirubin assay is substantially equivalent to the Roche Direct Bilirubin assay on the Hitachi® 717 Analyzer.

Both assays yield similar Performance Characteristics.

### Similarities:

- . Both assays are in vitro colorimetric assays.
- Both assays can be used for the quantitative determination of direct bilirubin. .
- Both assays yield similar clinical results. .
- Both assays are based on the reaction of bilirubin with a diazonium salt in the . presence of acid.

#### Differences:

- . Human serum and plasma are suitable specimens for the Direct Bilirubin assay and only human serum is a suitable specimen for Roche Direct Bilirubin assay.
- . There is a difference between the assay ranges.
- . There is a difference in the use of calibrators.

### Intended Use:

The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma.

Section II Page 2

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#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System and ARCHITECT® c8000™ System. The Direct Bilirubin assay method comparison yielded acceptable correlation with the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer. On the AEROSET System, the correlation coefficient = 0.995, slope = 1.08, and the Y-intercept = 0.21 mg/dL. On the ARCHITECT c8000 System, the correlation coefficient = 0.996, slope = 1.08, and the Y-intercept = 0.21 mg/dL. Precision studies were conducted using the Direct Bilirubin assay. Within-run, between-run, and between-day studies were performed using four levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 3.6 to 4.1%, Level 2 ranged from 0.9 to 2.6%, Level 3 ranged from 1.0 to 2.7%, and Level 4 ranged from 0.7 to 2.6 %. On the ARCHITECT c8000 System, the total %CV for Level 1 ranged from 3.0 to 3.6%, Level 2 ranged from 0.9 to 1.2%, Level 3 ranged from 1.3 to 1.5%, and Level 4 ranged from 0.8 to 1.1 %. The Direct Bilirubin assay range is 0.1 to 16.9 mg/dL. The limit of quantitation (sensitivity) of the Direct Bilirubin assay is 0.04 mg/dL on the AEROSET System and 0.04 mg/dL on the ARCHITECT c8000 System. These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer.

### Conclusion:

The Direct Bilirubin assay is substantially equivalent to the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Section II Page 3

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## 6 2002

Ms. Michele Smith-Waheed Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, TX 75038

Re: k022180

> Trade/Device Name: Direct bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total and direct) Test System Regulatory Class: Class II Product Code: CIG, JIT Dated: June 28, 2002 Received: July 3, 2002

Dear Ms. Smith-Waheed:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmamain.html".

Sincerely yours,

Steven Butman

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): KO22-180

Direct Bilirubin Device Name: . . .

Indications For Use:

The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma. Measurement of direct 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Veronica P. O'Brien for Di Juan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022180

Direct Bilirubin 510(k) 6/28/2002 Bil D 5 RI doc