The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Device Description

Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of Total Bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the analyte in the sample reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of bilirubin in the sample.

AI/ML Overview

The information provided describes the performance of the Abbott Laboratories TBil (Total Bilirubin) assay. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" with predefined thresholds for each performance characteristic. Instead, it demonstrates substantial equivalence to a predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Total Bilirubin assay) by showing comparable performance. The reported performance metrics are presented below:

Performance Characteristic	Reported Device Performance (TBil Assay)	Equivalence Justification/Predicate Performance
Correlation with Predicate	Correlation coefficient = 0.9925	Substantially equivalent to Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay, indicating similar clinical results.
Method Comparison (Slope)	Slope = 0.873	Part of the method comparison with the predicate device, contributing to the demonstration of substantial equivalence.
Method Comparison (Y-intercept)	Y-intercept = - 0.072 mg/dL	Part of the method comparison with the predicate device, contributing to the demonstration of substantial equivalence.
Precision (Within-run, %CV)	Not explicitly stated separately, but included in total %CV.	Studies were conducted using two levels of control material.
Precision (Between-run, %CV)	Not explicitly stated separately, but included in total %CV.	Studies were conducted using two levels of control material.
Precision (Between-day, %CV)	Not explicitly stated separately, but included in total %CV.	Studies were conducted using two levels of control material.
Precision (Total %CV, Level 1/Panel 111)	4.8%	Considered acceptable.
Precision (Total %CV, Level 2/Panel 112)	5.1%	Considered acceptable.
Linearity (Upper Limit)	20.0 mg/dL	Considered acceptable for the intended use.
Limit of Quantitation (Sensitivity)	0.264 mg/dL	Considered acceptable for the intended use.

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

The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies). It mentions that "comparative performance studies were conducted using the ALCYON™ Analyzer" and "precision studies were conducted using the Total Bilirubin assay... using two levels of control material."

Sample Size: Not explicitly stated for specific studies.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study focuses on the analytical performance of the device in a laboratory setting.

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

This type of information is not relevant or provided for this device. The device is an in vitro diagnostic assay for quantitative determination of a chemical analyte (Total Bilirubin). The ground truth for such devices is established by comparing the device's measurements to a reference method or validated predicate device, not by expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As mentioned above, this is an in vitro diagnostic assay, not a subjective diagnostic interpretation. The comparison is objective, based on measured values and statistical correlation.

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

Not applicable. This device is an automated in vitro diagnostic assay for chemical analysis, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

Yes, in essence. The studies described are of the device's standalone analytical performance. The "comparative performance studies" and "precision studies" evaluate the assay itself, operating as an algorithm within the ALCYON™ Analyzer, comparing its output to a predicate device and assessing its inherent variability and limits. There is no human-in-the-loop component in the direct measurement and quantification of bilirubin by the device.

7. The Type of Ground Truth Used

The "ground truth" for this in vitro diagnostic assay is implicitly the measurements obtained from the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay (K910591), which served as the predicate device. The performance of the new device (TBil) was compared against this established method.

8. The Sample Size for the Training Set

Not applicable/provided. This device is a traditional chemical assay, not a machine learning or AI algorithm that requires a "training set" in the computational learning sense. The assay's parameters would have been developed and optimized based on chemical principles and validation studies, not through a data-driven training process as typically understood for AI.

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

Not applicable. As explained in point 8, there is no "training set" in the context of this traditional in vitro diagnostic assay.

Summary

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K981336

1 1998 MAY

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 9, 1998
Device Trade or Proprietary Name:	TBil
Device Common/Usual Name or Classification Name:	Total Bilirubin
Classification Number/Class:	75CIG/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: 149813360

Test Description:

Substantial Equivalence:

The Total Bilirubin assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Total Bilirubin assay (K910591).

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of total bilirubin. .
Both assays yield similar clinical results. .

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Intended Use:

The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Total Bilirubin assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay. The correlation coefficient = 0.9925, slope = 0.873, and Y-intercept = - 0.072 mg/dL. Precision studies were conducted using the Total Bilirubin 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 4.8% and 5.1% for Level 2/Panel 112. The Total Bilirubin assay is linear up to 20.0 mg/dL. The limit of quantititation (sensitivity) of the Total Bilirubin assay is 0.264 mg/dL. These data demonstrate that the performance of the Total Bilirubin assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay.

Conclusion:

The Total Bilirubin assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay as demonstrated by results obtained in the studies.

Total Bilirubin 510(k) April 10, 1998 TBiliE2.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 is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an abstract symbol that resembles a bird or a person with outstretched arms. The text is in all caps and arranged in a circular fashion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

। MAY

Mark Littlefield . Section Manager, Requlatory Affairs Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038

K981336 Re : Total Bilirubin Regulatory Class: II Product Code: CIG Dated: April 9, 1998 Received: April 13, 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 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 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 Bitman

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): K98/336 Device Name: Total Bilirubin

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 1 Over-The-Counter Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.