The Albumin BCG assay is used for the quantitation of albumin in serum and plasma. 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 in human serum or plasma. 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 628 nm of the complex is directly proportional to the albumin concentration in the sample.

AI/ML Overview

The provided 510(k) summary for Abbott Laboratories' "Albumin BCG" assay details the acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the Albumin BCG assay are based on its performance characteristics, specifically comparison with a legally marketed predicate device (Boehringer Mannheim® Albumin BCG assay on the Hitachi® 717 Analyzer).

Acceptance Criteria Category	Specific Criteria/Metric	Target/Acceptance Threshold (compared to predicate)	Reported Device Performance (Albumin BCG assay)
Method Comparison	Correlation Coefficient	High (indicating strong linear relationship)	0.9935
	Slope	Close to 1 (indicating proportional agreement)	0.893
	Y-intercept	Close to 0 (indicating minimal constant bias)	0.643 g/dL
Precision	Within-run %CV	Low (indicating good repeatability)	Not explicitly stated as a target, but reported as low.
	Between-run %CV	Low (indicating good intermediate precision)	Not explicitly stated as a target, but reported as low.
	Between-day %CV	Low (indicating good reproducibility)	Not explicitly stated as a target, but reported as low.
	Total %CV (Level 1/Panel 101)	Low	0.8%
	Total %CV (Level 2/Panel 102)	Low	0.9%
Linearity	Linear range	Sufficient for clinical use, comparable to predicate	Up to 11.8 g/dL
Limit of Quantitation (Sensitivity)	Lower detection limit	Clinically appropriate, comparable to predicate	0.2 g/dL

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

The document does not explicitly state the sample size used for the test set in the method comparison study. It mentions "Comparative performance studies were conducted," but a specific number of samples or patients is not provided.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

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

This information is not applicable and not provided in the context of this 510(k) submission. For in vitro diagnostic assays for quantitative determination of a biomarker, the "ground truth" is typically the measurement obtained from a well-established and validated reference method (in this case, the predicate device). There is no mention of human expert interpretation for establishing ground truth as would be relevant for imaging or diagnostic aid devices.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the "ground truth" is established by the predicate device's performance, not by expert adjudication.

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 type of study is not applicable to this device. The Albumin BCG assay is an in vitro diagnostic (IVD) for quantitative measurement of albumin, not an AI-assisted diagnostic device that would involve human readers.

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 directly through chemical reaction and measurement, similar to an "algorithm only" in the sense that human interpretation of a visual output is not the primary function being assessed, but rather the accuracy and precision of the quantitative result. The performance characteristics described (correlation coefficient, slope, intercept, precision, linearity, sensitivity) are all measures of the assay's standalone performance.

7. The Type of Ground Truth Used:

The ground truth used for comparison is the performance of a legally marketed predicate device: the Boehringer Mannheim® Albumin BCG assay on the Hitachi® 717 Analyzer. This is a common method for establishing substantial equivalence for IVDs.

8. The Sample Size for the Training Set:

The document does not describe a "training set" in the context of an algorithmic or machine learning device. For IVDs, method development and optimization would occur, which might be analogous to "training," but the data from these phases are not typically referred to as a "training set" in the same way as for AI. The performance studies mentioned are for verification and validation.

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

Not applicable, as a "training set" in the AI sense is not described. The assay's chemical principles and optimization would have established its "ground truth" for its own development, but this is not detailed in the 510(k) summary. The comparison data relies on the established performance of the predicate device.

Summary

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K981758

510(k) Summary

Submitter's name/address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

JUN | 2 1998

Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 18, 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) May 18, 1998 Aero ALBGf.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 yield similar clinical results. .

Intended Use:

The Albumin BCG 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 BCG assay method comparison yielded acceptable correlation with the Boehringer Mannheim Albumin BCG assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9935, slope = 0.893, and Y-intercept = 0.643 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 101 is 0.8% and Level 2/Panel 102 is 0.9%. The Albumin BCG assay is linear up to 11.8 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) May 18, 1998 Aero ALBGf.lwp

Section II Page 2

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 2 1998

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

K981758 Re : Albumin BCG Requlatory Class: II Product Code: CIX Dated: May 18, 1998 Received: May 19, 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 qeneral controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good 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 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 Requlation (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 (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): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________ Albumin BCG

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981758

11 20000000

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

______________________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use OR V (Per 21 CFR 801.109) (Optional Format 1-2-96)

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.