The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement 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 conjugated bilirubin is oxidized to biliverdin. The resulting decrease in absorbance at 444 nm is directly proportional to the concentration of total bilirubin.

AI/ML Overview

The provided 510(k) summary describes the Abbott Laboratories TBil (Total Bilirubin) assay, an in vitro diagnostic device for the quantitative determination of total bilirubin in human serum or plasma.

This submission is a traditional 510(k) for a new device, not an AI/ML powered device. The document explicitly states that the device is an in vitro diagnostic assay and describes its chemical principle (oxidation of conjugated bilirubin to biliverdin). Therefore, many of the questions regarding AI/ML device validation (e.g., sample sizes for test/training sets, number of experts, adjudication methods) are not applicable.

Here's an analysis of the provided information, focusing on the relevant acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Metric	Reported Performance of TBil Assay	Predicate Device (Johnson & Johnson Vitros™ Total Bilirubin) Performance
Method Comparison	Correlation Coefficient	0.994	N/A (implied benchmark for correlation)
	Slope	1.055	N/A (implied benchmark for slope = 1)
	Y-intercept	0.009 mg/dL	N/A (implied benchmark for Y-intercept = 0)
Precision	Total %CV (Level 1/Panel 101)	5.6%	N/A (stated as "similar Performance Characteristics" for both)
	Total %CV (Level 2/Panel 102)	4.3%	N/A
Linearity	Upper Limit	Up to 23.38 mg/dL	N/A (difference between assay ranges noted, but specific predicate range not given)
Sensitivity	Limit of Quantitation	0.13 mg/dL	N/A

Study Proving Device Meets Acceptance Criteria:

A "comparative performance study" was conducted using the Abbott AEROSET™ System. This study compared the performance of the Abbott TBil assay with the predicate device, the Total Bilirubin on the Johnson & Johnson Vitros™ System. The results, as presented in the table above, demonstrated "acceptable correlation" and other performance characteristics, leading to the conclusion of "substantial equivalence."

2. Sample Size 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 or precision studies).
Data Provenance: The document does not specify the country of origin of the data. It implies the studies were conducted by Abbott Laboratories. The studies appear to be prospective in nature, as they involve actively "conducting" comparative performance studies and precision studies for the new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This is an in vitro diagnostic assay based on a chemical reaction, not an AI/ML device relying on expert image or data interpretation. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation is not applicable. The "ground truth" for method comparison would be the results obtained from the predicate device (Johnson & Johnson Vitros™ System), which is also a quantitative measurement system.

4. Adjudication Method for the Test Set

As this is a quantitative chemical assay and not an AI/ML device with subjective interpretations, adjudication methods are not applicable. The comparison is based on numerical agreement between the new device and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Abbott TBil assay is an automated in vitro diagnostic assay that provides a quantitative measurement.

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

The device is an automated in vitro diagnostic assay. Its performance, as described by linearity, sensitivity, and precision, represents its standalone performance without human interpretation in the loop beyond operating the instrument and collecting the sample. The "method comparison" also evaluates its standalone performance against another standalone device.

7. The Type of Ground Truth Used

The "ground truth" for the method comparison was the quantitative measurements obtained from the legally marketed predicate device (Johnson & Johnson Vitros™ System for Total Bilirubin). For precision, the ground truth refers to the intrinsic variability of the assay itself, demonstrating reproducibility around a given (control) concentration.

8. The Sample Size for the Training Set

This is an in vitro diagnostic assay that performs a chemical reaction, not an AI/ML device that requires a training set. Therefore, the concept of a "training set" in the context of machine learning is not applicable.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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K983133

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Senior Regulatory Affairs Specialist (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	September 4, 1998
Device Trade or Proprietary Name:	TBil
Device Common/Usual Name or Classification Name:	Total Bilirubin
Classification Number/Class:	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: KG83133

Test Description:

Substantial Equivalence:

The Total Bilirubin assay is substantially equivalent to the following device: Total Bilirubin (K962919) on the Johnson & Johnson® Vitros™ System.

Total Bilirubin 510(k) September 4, 1998 TBil_5_V1.lwp

Section II Page 1

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Both assays yield similar Performance Characteristics.

Similarities:

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.
. Both assays are based on the oxidation of bilirubin to biliverdin

Differences:

There is a difference between the assay range. .

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 AEROSET™ System. The Total Bilirubin assay method comparison yielded acceptable correlation with the Total Bilirubin on the Johnson & Johnson Vitros System. The correlation coefficient = 0.994, slope = 1.055, and Y-intercept = 0.009 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 101 is 5.6% and Level 2/Panel 102 is 4.3%. The Total Bilirubin assay is linear up to 23.38 mg/dL. The limit of quantitation (sensitivity) for the Total Bilirubin assay is 0.13 mg/dL. These data demonstrate that the performance of the Total Bilirubin assay is substantially equivalent to the performance of the Total Bilirubin on the Johnson & Johnson Vitros System.

Total Bilirubin 510(k) September 4. 1998 TBil_5_V1.lwp

Section II Page 2

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Conclusion:

The Total Bilirubin assay is substantially equivalent to the Total Bilirubin on the Johnson & Johnson Vitros System as demonstrated by results obtained in the studies.

Total Bilirubin 510(k)
September 4, 1998 TBil_5_V1.lwp

Section II Page 3

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting a sense of community and support.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 6 1998

Linda Morris Senior Requlatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038

Re : K983133 Total Bilirubin Regulatory Class: II Product Code: CIG, JIX September 4, 1998 Dated: Received: September 8, 1998

Dear Ms. Morris:

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, 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 regulations 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 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 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): H983133

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devises
510(k) Number. h 983933

(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)

Total Bilirubin 510(k) September 4, 1998 TBil 5 VI.Jwn

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.