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

Device 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.

AI/ML Overview

The provided text describes a 510(k) submission for the Albumin BCG assay, which is an in vitro diagnostic device. The study described focuses on demonstrating substantial equivalence to a predicate device, rather than a typical clinical efficacy study with acceptance criteria often seen for AI/ML devices. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, etc.) is not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated)	Reported Device Performance
Correlation Coefficient (with predicate)	0.9864
Slope (with predicate)	0.844
Y-intercept (with predicate)	0.699 g/dL
Total %CV for Level 1/Panel 111	2.1%
Total %CV for Level 2/Panel 112	2.3%
Linearity	Up to 7.0 g/dL
Limit of Quantitation (Sensitivity)	0.2 g/dL

Note: The acceptance criteria themselves are implied by the reported performance figures being deemed "acceptable" and demonstrating "substantial equivalence." No explicit numerical thresholds for acceptance were stated, but the values indicate a high degree of correlation and precision.

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

Sample Size: Not explicitly stated. The text mentions "comparative performance studies" and "precision studies" conducted using control material, but does not provide the number of patient samples or the specific sample sizes for these studies.
Data Provenance: Not explicitly stated. The studies were conducted using the ALCYON™ Analyzer, but the country of origin of the data or whether it was retrospective or prospective is not mentioned.

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

This is Not Applicable for this type of in vitro diagnostic device 510(k) submission. Ground truth for clinical chemistry assays is typically established through reference methods and internal validation, not through expert consensus in the way imaging or diagnostic AI algorithms might require.

4. Adjudication Method for the Test Set

This is Not Applicable. Clinical chemistry assays do not typically involve adjudication by experts for establishing ground truth; rather, performance is assessed against established measurement principles and reference materials.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is Not Applicable. The device is an in vitro diagnostic assay, not an AI-powered diagnostic system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

The Albumin BCG assay is a standalone in vitro diagnostic assay. Its performance is evaluated intrinsically through its chemical reaction and measurement capabilities. Its "performance" refers to the accuracy and precision of its quantitative output, not its ability to interpret complex data that a human might also interpret.

7. The Type of Ground Truth Used

The ground truth for this device's performance assessment is largely established by:

Predicate Device Comparison: The Boehringer Mannheim® Albumin BCG assay (K81194) on the Hitachi® 717 Analyzer served as the reference standard for comparison, implying its results were considered "ground truth" for demonstrating substantial equivalence.
Control Material: Precision studies were performed using "two levels of control material," which are laboratory standards with known concentrations, serving as a form of ground truth for evaluating assay variability.

8. The Sample Size for the Training Set

This is Not Applicable. The Albumin BCG assay is a chemical-based in vitro diagnostic method, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying principles are chemical reactions and spectrophotometric measurements.

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

This is Not Applicable for the same reason as above. There is no concept of a "training set" for this type of device.

Summary

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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 (972) 518-7861 Fax (972) 753-3367

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:

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

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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 (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 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 (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 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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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.