The Direct Bilirubin assay is used for the quantitation of direct 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

Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum or plasma. The Direct 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 direct bilirubin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DBil device, based on the provided text:

Acceptance Criteria and Device Performance

The device's performance was compared to a legally marketed predicate device, the Wako Diagnostics Direct Bilirubin assay on the Hitachi 717 Analyzer, to establish substantial equivalence.

Acceptance Criteria (Predicate Performance)	Reported Device Performance (DBil)
Correlation Coefficient (vs. Predicate)	0.9878
Slope (vs. Predicate)	1.168
Y-intercept (vs. Predicate)	0.081 mg/dL
Total %CV Level 1	4.0%
Total %CV Level 2	3.8%
Linearity	Up to 50.2 mg/dL
Limit of Quantitation (Sensitivity)	0.11 mg/dL

Note: The document doesn't explicitly state numerical acceptance criteria for correlation, slope, and y-intercept, but rather indicates that the "method comparison yielded acceptable correlation" and that the data "demonstrate that the performance...is substantially equivalent." The values provided are the reported performance of the DBil device during the comparative studies.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "comparative performance studies" and "precision studies" conducted using "two levels of control material" (for precision) and "human serum or plasma" generally, but does not provide specific numbers of patient samples or the size of the test set used for method comparison.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic assay, and the "ground truth" for its performance is typically established through comparison to a well-characterized predicate device and through analytical performance studies (precision, linearity, sensitivity). Expert consensus for ground truth is not relevant in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. See point 2.
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 is not an AI-assisted diagnostic device, but a clinical chemistry assay.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The study evaluated the "Direct Bilirubin assay" which is an in vitro diagnostic test, performing in a standalone manner without human-in-the-loop performance influencing the assay's output. Its performance characteristics (correlation, precision, linearity, sensitivity) were measured intrinsically.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance was established through:
- Comparison to a legally marketed predicate device: The Wako Diagnostics Direct Bilirubin assay on the Hitachi 717 Analyzer served as the reference for comparative studies, with its established performance characteristics implicitly acting as a form of "ground truth" for substantial equivalence.
- Analytical performance metrics: Precision, linearity, and limit of quantitation (sensitivity) were determined experimentally for the DBil assay itself.
The sample size for the training set: Not applicable. This is a chemical assay, not a machine learning or AI-based device, so there is no "training set" in the conventional sense.
How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Summary

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K98194B

Jul 2 2 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) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	June 1, 1998
Device Trade or Proprietary Name:	DBil
Device Common/Usual Name or Classification Name:	Direct 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:

Test Description:

Substantial Equivalence:

The Direct Bilirubin assay is substantially equivalent to the following device:

Wako Diagnostics Direct Bilirubin assay (K970985) on the Hitachi® 717 Analyzer .
Direct Bilirubin 510(k) June 1, 1998 DBIL.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 direct 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 Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Direct Bilirubin assay method comparison yielded acceptable correlation with the Wako Diagnostics Direct Bilirubin assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9878, slope = 1.168, and Y-intercept = 0.081 mg/dL. Precision studies were conducted using the Direct 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 4.0% and Level 2/Panel 102 is 3.8%. The Direct Bilirubin assay is linear up to 50.2 mg/dL. The limit of quantitation (sensitivity) for the Direct Bilirubin assay is 0.11 mg/dL. These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Wako Diagnostics Direct Bilirubin assay on the Hitachi 717 Analyzer.

Direct Bilirubin 510(k) June 1, 1998 DBIL.lwp

Section II Page 2

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Conclusion:

The Direct Bilirubin assay is substantially equivalent to the Wako Diagnostics Direct Bilirubin assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Direct Bilirubin 510(k)
June 1, 1998
DBIL.lwp

Section II Page 3

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

JUL 22 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark Littlefield Section Manager, Regulatory Affairs ABBOTT LABORATORIES 1920 Hurd Drive Irving, Texas 75038

Re : K981943 Trade Name: DBil Regulatory Class: II Product Code: CIG Dated: June 1, 1998 Received: June 3, 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 requirement, 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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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): _ _ 98/943

Direct Bilirubin Device Name: ________

Indications For Use:

Division Sign Off

(Division Sign-Off) Division of Clinical Laborator 510(k) Number

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

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

(Optional Format 1-2-96)

00000000

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.