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.

Device 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Albumin BCP device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Similar clinical results to predicate device	Achieved. The study aimed to demonstrate substantial equivalence to the Boehringer Mannheim Albumin BCP assay (K844426) on the Hitachi 717 Analyzer.
Method Comparison (Correlation)	Acceptable correlation with predicate device	Correlation coefficient = 0.9914, slope = 1.056, and Y-intercept = - 0.001 g/dL. (These metrics are generally accepted as indicating strong correlation in clinical chemistry method comparison studies when the correlation coefficient is close to 1, the slope is close to 1, and the y-intercept is close to 0)
Precision	Acceptable within-run, between-run, and between-day studies for two levels of control material	Total %CV for Level 1/Panel 101 is 0.8% and Level 2/Panel 102 is 0.8%. (These CVs are very low, indicating high precision.)
Linearity	Linear range of measurement	Linear up to 13.1 g/dL.
Limit of Quantitation (Sensitivity)	Defined minimum quantifiable concentration	0.05 g/dL.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance studies (method comparison, precision, linearity, and sensitivity). It mentions "two levels of control material" for precision studies, but not the number of individual samples or patient samples.
Data Provenance: Not explicitly stated. The document refers to "human serum or plasma" for the intended use and "comparative performance studies," implying that the data would be based on human samples. However, the country of origin or whether the data was retrospective or prospective is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is an in vitro diagnostic assay that measures a quantitative biomarker (albumin). The "ground truth" for such devices is established through established analytical methods and reference standards, not typically through human expert adjudication as would be the case for image-based diagnostic aids. The performance is assessed against the results of a predicate device (Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer) as the comparative standard.

4. Adjudication Method for the Test Set:

Not applicable. See explanation above. The comparison is analytical, not based on human judgment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is not relevant for this type of in vitro diagnostic device. MRMC studies are typically performed for devices that assist human readers (e.g., radiologists, pathologists) in interpreting medical images or complex data. The Albumin BCP assay provides a direct quantitative measurement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes. The performance characteristics presented (correlation, precision, linearity, sensitivity) describe the standalone performance of the Albumin BCP assay itself when run on the AEROSET™ System. There is no human intervention in interpreting the output of this quantitative assay; the result is a numerical value.

7. Type of Ground Truth Used:

Reference Method/Predicate Device Comparison: The "ground truth" or reference for evaluating this new device's performance was the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices.
Established Analytical Principles: The linearity and sensitivity are determined based on the assay's ability to accurately measure known concentrations or detect low levels of albumin, respectively. Precision is measured by the reproducibility of results for control materials with known concentrations.

8. Sample Size for the Training Set:

Not applicable. The Albumin BCP assay is a chemical assay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a device would involve optimizing the chemical reagents and instrument parameters during its development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As it's not a machine learning model, a training set and its associated ground truth are not relevant concepts. The developmental process would rely on chemical principles and laboratory testing to ensure the assay reagents and methodology produce accurate and reliable quantitative results.

Summary

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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 (972) 581-6062 Fax (972) 753-3367

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:

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

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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

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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 (770)488-7655.

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 (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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)
Prescription Use(Per 21 CFR 801.109)

Over-The-Counter Use
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(Optional Format 1-2-96)

00000006

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
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.(b)
Classification. Class II.