ALBG

K981468 · Abbott Laboratories · CIX · May 27, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981468
• Device Name: ALBG
• Applicant: Abbott Laboratories
• Product Code: CIX · Clinical Chemistry
• Decision Date: May 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The Albumin BCG assay is used for the quantitation of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Story

Albumin BCG is an in vitro diagnostic clinical chemistry assay. It measures albumin concentration in human serum samples. The assay utilizes bromcresol green, which binds specifically to albumin to form a colored complex. The device measures the absorbance of this complex at 600 nm; absorbance is directly proportional to albumin concentration. The assay is intended for use on clinical chemistry analyzers (e.g., ALCYON Analyzer) by laboratory professionals. Results are used by clinicians to diagnose and monitor liver and kidney diseases.

Clinical Evidence

Bench testing only. Method comparison study performed on the ALCYON Analyzer against the predicate (Hitachi 717) showed a correlation coefficient of 0.9864, slope of 0.844, and Y-intercept of 0.699 g/dL. Precision studies demonstrated total %CV of 2.1% (Level 1) and 2.3% (Level 2). The assay is linear up to 7.0 g/dL with a limit of quantitation of 0.2 g/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay using bromcresol green colorimetric binding. Measures absorbance at 600 nm. Linear range up to 7.0 g/dL; sensitivity 0.2 g/dL. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of albumin in human serum to aid in the diagnosis and treatment of liver or kidney diseases.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• Boehringer Mannheim Albumin BCG assay (K81194)

Submission Summary (Full Text)

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# 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 22, 1998 |
|--------------------------------------------------|----------------|
| Device Trade or Proprietary Name: | AlbG |
| Device Common/Usual Name or Classification Name: | Albumin BCG |
| Classification Number/Class: | 75CIX/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:

#### Test Description:

Albumin BCG is an in vitro diagnostic assay for the quantitative determination of albumin human serum. The Albumin BCG assay is a clinical chemistry assay in which the analyte in the sample binds specifically to bromcresol green to produce a colored complex. The absorbance at 600 nm of the complex is directly proportional to the albumin concentration in the sample.

### Substantial Equivalence:

The Albumin BCG assay is substantially equivalent to the Boehringer Mannheim® Albumin BCG assay (K81194) on the Hitachi® 717 Analyzer.

This assay yields similar Performance Characteristics.

Albumin BCG 510(k) April 22, 1998 ALBGE2.lwp

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Similarities to Boehringer Mannheim:

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

Differences to Boehringer Mannheim:

- . There is a minor difference in the assay range.
#### Intended Use:

The Albumin BCG assay is used for the quantitation of albumin in human serum.

#### Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Albumin BCG assay method comparison yielded acceptable correlation with the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9864, slope = 0.844, and the Y-intercept = 0.699 g/dL. Precision studies were conducted using the Albumin BCG 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 2.1% and Level 2/Panel 112 is 2.3%. The Albumin BCG assay is linear up to 7.0 g/dL. The limit of quantitation (sensitivity) of the Albumin BCG assay is 0.2 g/dL. These data demonstrate that the performance of the Albumin BCG assay is substantially equivalent to the performance of the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer.

#### Conclusion:

The Albumin BCG assay is substantially equivalent to the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Albumin BCG 510(k) April 22, 1998 ALBGE2.lwp

Section II Page 2

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 7 1998

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive 75038 Irving, Texas

K981468 Re : AlbG Requlatory Class: II Product Code: CIX Dated: April 22, 1998 Received: April 23, 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 marice 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.

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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 leqally 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 Litman

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): _ bc 98 | 468

Device Name: _____________ Albumin BCG

Indications For Use:

The Albumin BCG assay is used for the quantitation of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number h981468

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

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

(Optional Format 1-2-96)

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