ALBP

K981814 · Abbott Laboratories · CJW · Jul 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981814
• Device Name: ALBP
• Applicant: Abbott Laboratories
• Product Code: CJW · Clinical Chemistry
• Decision Date: Jul 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The Albumin BCP assay is used for the quantitation of albumin in human serum and plasma.

Device Story

Albumin BCP is an in vitro diagnostic clinical chemistry assay. It utilizes a bromocresol purple dye in acidic media to bind albumin in human serum or plasma samples, forming a colored complex. The device measures the absorbance of this complex at 604 nm using a clinical chemistry analyzer (e.g., AEROSET System). The measured absorbance is directly proportional to the albumin concentration in the sample. The assay is intended for use by laboratory professionals in clinical settings to assist in diagnosing and managing liver and kidney diseases.

Clinical Evidence

Bench testing only. Method comparison study against the predicate (Hitachi 717) yielded a correlation coefficient of 0.9914, slope of 1.056, and Y-intercept of -0.001 g/dL. Precision studies showed total %CV of 0.8% for both control levels. The assay demonstrated linearity up to 13.1 g/dL and a limit of quantitation (sensitivity) of 0.05 g/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay; bromocresol purple dye-binding method; photometric detection at 604 nm; linear range up to 13.1 g/dL; sensitivity 0.05 g/dL.

Indications for Use

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

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 BCP Assay (K844426)

Submission Summary (Full Text)

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### JUL 22 1998

# 510(k) Summary

X981814

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

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

| Date of Preparation of this Summary: | May 21, 1998 |
|--------------------------------------------------|-----------------|
| Device Trade or Proprietary Name: | AlbP |
| Device Common/Usual Name or Classification Name: | Albumin BCP |
| Classification Number/Class: | 75CJW /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 BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to a bromocresol purple dye in acidic media to form a colored complex. The absorbance of the albumin chromophore complex is measured at 604 nm and is directly proportional to the concentration of albumin present in the sample.

#### Substantial Equivalence:

The Albumin BCP assay is substantially equivalent to the Boehringer Mannheim® Albumin BCP Assay (K844426) on the Hitachi® 717 Analyzer.

These assays yield similar Performance Characteristics.

Albumin BCP 510(k) May 20, 1998 AlbBCPf.lwp

Section II Page 1

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#### Similarities:

- 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.

#### Intended Use:

The Albumin BCP assay is used for the quantitation of albumin in human serum and plasma.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Albumin BCP assay method comparison vielded acceptable correlation with the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9914, slope = 1.056, and Y-intercept = - 0.001 g/dL. Precision studies were conducted using the Albumin BCP assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 0.8% and Level 2/Panel 102 is 0.8%. The Albumin BCP assay is linear up to 13.1 g/dL. The limit of quantititation (sensitivity) of the Albumin BCP assay is 0.05 g/dL. These data demonstrate that the performance of the Albumin BCP assay is substantially equivalent to the performance of the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer.

#### Conclusion:

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

Albumin BCP 510(k) May 20, 1998 AlbBCPf.lwp

Section II Page 2

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JUL 221998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark Littlefield Section Manager, Regulatory Affairs ABBOTT LABORATORIES 1920 Hurd Drive Irving, Texas 75038

Re : K981814 Trade Name: AlbP Regulatory Class: II Product Code: CJW Dated: May 21, 1998 Received: May 22, 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 (3,01) Additionally, for questions on the promotion and 594-4588. 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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):

Device Name:

Indications For Use:

The Albumin BCP is used for the quantitation of albumin in human serum or plasma. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.

**(Division Sign-Off)**

Division of Clinical Laboratory Devices
510(k) Number UC981814

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
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