The Albumin BCP assay is used for the quantitation of albumin in human serum. 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. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to bromcresol purple. The absorbance of the complex is measured at 600 nm and is directly proportional to the albumin concentration in the sample.

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott Laboratories Albumin BCP assay, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document is a 510(k) summary for the Abbott Laboratories Albumin BCP assay, indicating that it is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The core of this submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by the sponsor's demonstration of substantial equivalence to a legally marketed predicate device (Boehringer Mannheim Albumin BCP Assay on the Hitachi 717 Analyzer). Therefore, the acceptance criteria are that the new device's performance characteristics are "similar" or "acceptable" in comparison to the predicate. The "reported device performance" refers to the results obtained for the Abbott Albumin BCP assay.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Abbott Albumin BCP)
Method Comparison	Acceptable correlation with predicate device, similar clinical results.	Correlation coefficient = 0.9855, slope = 0.950, Y-intercept = 0.198 g/dL.
Precision	Acceptable within-run, between-run, and between-day variability.	Total %CV for Level 1/Panel 111 = 2.3%, Level 2/Panel 112 = 2.5%.
Linearity/Assay Range	Suitable for intended use, comparable to predicate.	Linear up to 7.0 g/dL.
Sensitivity (Limit of Quantitation)	Suitable for intended use, comparable to predicate.	Limit of quantitation = 0.1 g/dL.

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

The document provides the following information:

Sample Size: The exact number of samples (individual patient samples) in the "comparative performance studies" for method comparison is not explicitly stated. It mentions "two levels of control material" for precision studies, but this refers to quality control samples, not patient samples for method comparison.
Data Provenance: The document does not specify the country of origin of the data. The study involved "human serum," but whether it was prospective or retrospective is not explicitly stated. Given that it's a 510(k) for an in vitro diagnostic, these studies are typically performed with collected patient samples, which could be retrospective (archived samples) or prospective (newly collected samples specifically for the study).

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

This type of information is not applicable to this 510(k) submission. For quantitative in vitro diagnostic assays like this, "ground truth" is typically established by:

Reference Methods: Highly accurate and precise analytical methods.
Predicate Device: In this case, the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer itself serves as the "standard" against which the new device is compared to establish substantial equivalence.

There were no human experts adjudicating images or clinical outcomes to establish ground truth for this type of device.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used typically in studies involving subjective interpretation (e.g., radiology, pathology slides) to resolve discrepancies between multiple readers. For a quantitative clinical chemistry assay, the output is a numerical value, and comparison is statistical, not based on human expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This submission is for an in vitro diagnostic assay, which is an automated or semi-automated laboratory test, not an AI-powered image analysis or clinical decision support tool designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The performance characteristics reported (method comparison, precision, linearity, sensitivity) are all standalone performance data of the Abbott Albumin BCP assay. The device itself (the assay and its measurement on the ALCYON™ Analyzer) operates without continuous human intervention in the measurement process to produce the quantitative albumin value.

7. The Type of Ground Truth Used

For method comparison, the "ground truth" was effectively the measurements obtained from the legally marketed predicate device, the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. The goal was to show that the new device's results are sufficiently similar to those of the predicate. For precision, linearity, and sensitivity, the "ground truth" or reference values are established through rigorous analytical testing using known concentrations or appropriate statistical methods.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the assay itself. For clinical chemistry assays like this, there isn't typically a "training set" in the machine learning sense. The assay method is developed and validated, and its performance characteristics are then evaluated. The term "training set" is more relevant for AI/ML-based devices. Development would involve extensive testing and optimization, but not usually in a "training set" / "test set" paradigm.

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

Since there is no explicit "training set" mentioned in the context of machine learning, this question is not applicable. The "ground truth" for the development and validation of the chemical assay would have been established through established analytical chemistry principles, reference materials, and comparison to other validated methods during the assay's development prior to the 510(k) submission.

Summary

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K981457

MAY 27 1998

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 22, 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.

Both assays vield similar Performance Characteristics.

Albumin BCP 510(k) April 22, 1998 Albbcp2E.lwp

Section II Page 1

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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 yield similar clinical results. .

Differences to Boehringer Mannheim:

There is a minor difference in the assay range. .

Intended Use:

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

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Albumin BCP assay method comparison yielded acceptable correlation with the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9855, slope = 0.950, and Y-intercept = 0.198 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 111 is 2.3% and Level 2/Panel 112 is 2.5%. The Albumin BCP assay is linear up to 7.0 g/dL. The limit of quantititation (sensitivity) of the Albumin BCP assay is 0.1 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) April 22, 1998 Albbcp2E.lwp

Section II Page 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or wing-like shape, positioned to the right. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in uppercase and appears to be in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 27 1998

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

K981457 Re: AlbP Regulatory Class: II Product Code: CJW 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 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 Regulations, 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 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 (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 (301) 594-4588. Additionally, for questions on the promotion and 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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): ____________________________________________________________________________________________________________________________________________________

Albumin BCP__ Device Name: _______________

Indications For Use:

The Albumin BCP assay is used for the quantitation of albumin in human serum. 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 k98/457

(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)

000000000

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.