The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum or plasma. Measurements 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 reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of direct bilirubin in the sample and can be measured at 550 nm.

AI/ML Overview

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for the Abbott Laboratories DBil (Alcyon Direct Bilirubin) assay.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Method Comparison	Acceptable correlation with predicate device (Roche Cobas Mira Plus Direct Bilirubin assay) and another established method (Boehringer Mannheim Direct Bilirubin assay on Hitachi 717 analyzer). Specific criteria likely involved correlation coefficients near 1, and slopes and intercepts indicative of good agreement.	Vs. Roche Cobas Mira Plus: Correlation coefficient = 0.997, slope = 0.77, Y-intercept = 0.08 mg/dL. Reported as "acceptable correlation." Vs. Boehringer Mannheim (Hitachi 717): Correlation coefficient = 0.996, slope = 1.08, Y-intercept = -0.03 mg/dL. Reported as "acceptable correlation."
Precision	Total %CV within acceptable clinical limits for two levels of control material (not explicitly stated, but implied by "acceptable").	Total %CV (all studies combined): Level 1/Panel 111: ranged from 5.9% to 10.4% Level 2/Panel 112: ranged from 2.7% to 3.0% (across within-run, between-run, and between-day studies).
Linearity	Linear range up to a certain concentration (not explicitly stated, but implied by "linear up to").	Linear up to 10 mg/dL.
Limit of Quantitation (Sensitivity)	Below a clinically relevant threshold (not explicitly stated, but implied by "sensitivity").	0.1 mg/dL.
Substantial Equivalence	Performance characteristics similar to the predicate device.	"These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay." The conclusion states, "The Direct Bilirubin assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay as demonstrated by results obtained in the studies."

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

Sample Size for Test Set: The document does not explicitly state the number of patient samples used in the method comparison studies. It mentions "two levels of control material" for precision studies but not the number of replicates or runs.
Data Provenance: Not specified. It's likely retrospective, given the nature of the method comparison and precision studies often performed in a lab setting, but this is not explicitly stated. The country of origin is also not mentioned.

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

This information is not applicable to this type of device. The ground truth for this device (a quantitative in vitro diagnostic assay) is established by the reference methods themselves (the predicate device and the Boehringer Mannheim assay). No human experts were used to establish a "ground truth" for the test set in the traditional sense of diagnostic imaging or clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative chemical assay, not an interpretation-based diagnostic device requiring adjudication of human readings. The "adjudication" is inherent in the numerical results obtained from the reference methods.

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 is an in vitro diagnostic assay, not a device that assists human readers in interpreting images or data. Therefore, an MRMC study and effects on human reader improvement are not relevant.

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

Yes, this was a standalone performance study. The entire study focuses on the analytical performance of the DBil assay itself, without any human-in-the-loop component for interpretation or diagnosis. The results directly reflect the algorithm's (assay's) ability to quantify direct bilirubin.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by:
- Predicate Device: The Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay (K910593). This is a previously cleared, legally marketed device.
- Established Method: The Boehringer Mannheim Direct Bilirubin assay on the Hitachi 717 analyzer. This represents another recognized and established method for direct bilirubin measurement.
- Known Concentration Control Materials: For precision studies, "control material" with known or target concentrations would have been used.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional chemical assay, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The assay's parameters are based on established chemical principles, not learned from a dataset.

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

Not applicable (as per point 8).

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

Date of Preparation of this Summary:	April 13, 1999
Device Trade or Proprietary Name:	DBil
Device Common/Usual Name or Classification Name:	Modification to Alcyon 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: K991175.

Test Description:

Substantial Equivalence:

The Direct Bilirubin assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Direct Bilirubin assay (K910593).

Both assays vield similar Performance Characteristics.

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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.

Differences:

. There is a minor 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 ALCYON™ Analyzer, The Direct Bilirubin assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay, the correlation coefficient = 0.997, slope = 0.77, and Y-intercept = 0.08 mg/dL. The Direct Bilirubin assay method comparison yielded acceptable correlation with the Boehringer Mannheim Direct Bilirubin assay on the Hitachi 717 analyzer, the correlation coefficient = 0.996, slope = 1.08. and Y-intercept = -0.03 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 111 ranged from 5.9 to 10.4% and Level 2/Panel 112 ranged from 2.7 to 3.0%. The Direct Bilirubin assay is linear up to 10 mg/dL. The limit of quantitation (sensitivity) for the Direct Bilirubin assay is 0.1 mg/dL. These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay.

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Conclusion:

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

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 8 1999

Mark Littlefield Abbott Laboratories ADD Regulatory Affairs 1920 Hurd Drive Irving, TX 75038

K991175 Re : Trade Name: Abbott Alcyon Direct Bilirubin Requlatory Class: II Product Code: CIG Dated: March 25, 1999 Received: March 29, 1999

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 legally marketed predicate 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 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 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 requlatory action. In addition, FDA may publish further announcements 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K991175_____

Device Name: Modification to ALCYON Direct Bilirubin

Indications For Use:

Alan Cooper
(Division Sign-Off)

ry 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 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.