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

The Abbott Laboratories Direct Bilirubin assay is an in vitro diagnostic assay intended for the quantitative determination of direct bilirubin in human serum or plasma. The device functions by reacting conjugated bilirubin with diazotized sulfanilic 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.

The study that proves the device meets the acceptance criteria is a comparative performance study against the predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Direct Bilirubin assay (K910593).

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Correlation to Predicate Device
Correlation Coefficient	0.9969
Slope	1.199
Y-intercept	0.369 mg/dL
Precision
Total %CV (Level 1/Panel 111)	6.7%
Total %CV (Level 2/Panel 112)	2.8%
Linearity (Assay Range)	Up to 16 mg/dL
Limit of Quantitation (Sensitivity)	0.3 mg/dL

Note: The document states "Both assays yield similar Performance Characteristics" and "The Direct Bilirubin assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay." The specific numerical acceptance criteria for correlation coefficient, slope, and y-intercept are not explicitly stated, but the reported values of 0.9969, 1.199, and 0.369 mg/dL respectively, are presented as acceptable for demonstrating substantial equivalence.

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).
The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study design is a comparison to a predicate device, not a human expert-based ground truth establishment. The ground truth for this type of IVD is typically the analytical result from the predicate device or a reference method.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for this type of analytical performance study. The comparison is objective, based on quantitative measurements.

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 is not an MRMC comparative effectiveness study involving human readers or AI assistance. It is an analytical performance study of an in vitro diagnostic assay.

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

This is a standalone diagnostic assay; its performance is evaluated based on its ability to quantitatively determine direct bilirubin, not in conjunction with human interpretation in the context of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the comparative study was the results obtained from the predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Direct Bilirubin assay.

8. The sample size for the training set:

This is an analytical performance study of a diagnostic assay, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" for this type of diagnostic assay.

Summary

{0}------------------------------------------------

K981222

APR 2 4 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) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 02, 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: K981222

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.

Direct Bilirubin 510(k) April 2, 1998 DBilfE2.lwp

Section II Page 1

Image /page/0/Picture/15 description: The image shows a sequence of numbers. The sequence is composed of zeros and ones. Specifically, the sequence is 0000011.

{1}------------------------------------------------

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 = 0.9969, slope = 1.199, and Y-intercept = 0.369 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 is 6.7% and Level 2/Panel 112 is 2.8%. The Direct Bilirubin assay is linear up to 16 mg/dL. The limit of quantitation (sensitivity) for the Direct Bilirubin assay is 0.3 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.

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.

Direct Bilirubin 510(k) April 2, 1998 DBifE2 lwp

Section II Page 2

Image /page/1/Picture/14 description: The image shows the number 0000012. The number is written in a bold, sans-serif font. The digits are evenly spaced and aligned horizontally. The number is likely a serial number or identification number.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 4 1998

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

Re: K981222 Direct Bilirubin Regulatory Class: II Product Code: CIG Dated: April 2, 1998 Received: April 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 marked is substantially equivalent (for the indications for use stated in the exclosure) 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. ਚੋ 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 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 requlations.

{3}------------------------------------------------

Page 2

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

{4}------------------------------------------------

510(k) Number (if known):

Device Name: Direct Bilirubin

Indications For Use:

(Division Sign-Off)
Division of
510(k) Number 12981222

(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.