The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma on the ARCHITECT c8000 system. Measurement of total 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.

A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Device Description

ARCHITECT Total Bilirubin is an in vitro diagnostic assay for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. Total (conjugated and unconjugated) bilirubin couples with the diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration.

AI/ML Overview

This document is a 510(k) summary for the ARCHITECT Total Bilirubin assay. This device is an in vitro diagnostic assay, and therefore the acceptance criteria and study details are focused on analytical performance, not clinical performance based on human reader interpretations.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "correlation coefficient must be > 0.99"). Instead, the document states generally that the method comparison "yielded acceptable correlation" and that the data "demonstrate the performance of the modified ARCHITECT Total Bilirubin assay is substantially equivalent to the performance of Abbott Total Bilirubin assay." The reported device performance metrics are provided.

Performance Metric Area	Specific Criterion/Test	Intended Outcome (Acceptance Criteria - Implicit)	Reported Device Performance
Method Comparison (Adult Application)	Correlation with original Total Bilirubin assay	Acceptable correlation	Correlation coefficient: 0.9991
			Slope: 0.98
			Y-intercept: 0.07 mg/dL
Method Comparison (Neonate Application)	Correlation with Roche Total Bilirubin assay	Acceptable correlation	Correlation coefficient: 0.9967
			Slope: 0.99
			Y-intercept: 0.32 mg/dL
Precision	Total %CV for various levels	Acceptable precision	Level 1: 1.96%
			Level 2: 1.43%
			Level 3: 1.20%
			Level 4: 1.00%
Linearity		Linear range	0.1 to 25.0 mg/dL
Functional Sensitivity (Limit of Quantitation)			< 0.1 mg/dL
Limit of Detection (LOD)			0.05 mg/dL

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

Adult Application Test Set: 138 adult serum samples, ranging from 0.11 to 23.96 mg/dL.
Neonate Application Test Set: 54 neonate serum samples, ranging from 0.94 to 19.05 mg/dL.
Data Provenance: The document does not specify the country of origin. The studies appear to be retrospective as they are testing existing samples against established methods.

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

Not applicable for this type of in vitro diagnostic device study. The "ground truth" is established by the results of a predicate or reference device/method (Abbott Total Bilirubin assay or Roche Total Bilirubin assay on Hitachi 717 Analyzer), not by human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The comparisons are quantitative measurements between devices, not human expert adjudications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 device, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

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

Yes, this study represents a standalone performance evaluation of the ARCHITECT Total Bilirubin assay. It's evaluating the automated assay's ability to measure total bilirubin.

7. The Type of Ground Truth Used

The "ground truth" (or reference method) used for the test sets was the results obtained from:

Adult Application: The original Abbott Total Bilirubin assay (K060574).
Neonate Application: The Roche Total Bilirubin assay on the Hitachi 717 Analyzer.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning or AI. For in vitro diagnostic assays, the calibration and optimization (which would be analogous to "training") of the assay's reagents and instrument parameters would have occurred during its development, but the sample size for that process is not detailed here. The described studies are primarily validation/verification testing.

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

Not explicitly stated or applicable as in AI/ML contexts. The "ground truth" for calibrating and developing the assay would typically be established through highly characterized reference materials, pure chemical standards, and potentially reference measurement procedures, all following established laboratory practices for quantitative analytical assays.

Summary

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

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 14, 2019

Abbott Laboratories Linda Morris 1921 Hurd Drive Irving, TX 75038

Re: K121985

Trade/Device Name: ARCHITECT Total Bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin Test system Regulatory Class: Class II Product Code: CIG, MQM Dated: December 20, 2012 Received: December 21, 2012

Dear Linda Morris:

This letter corrects our substantially equivalent letter of February 1, 2013.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K121985

Device Name: ARCHITECT Total Bilirubin

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR .

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K121985 510(k) ==

Page 1 of 1

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

121985

510(k) Summary

FEB 0 .1 2013

Submitter's Name/Address

Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

...

Contact Person Linda Morris Senior Regulatory Specialist MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-6960

Date of Preparation of this Summary: Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Classification Number/Class:

January 30, 2013 ARCHITECT Total Bilirubin Total Bilirubin Reagent

CIG/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: 10 - - - -

Test Description:

Total Bilirubin 510(k) Revised January31, 2013

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

Substantial Equivalence:

The modified ARCHITECT Total Bilirubin assay is substantially equivalent to the Abbott Total Bilirubin assay (K060574) on the ARCHITECT c8000 Analyzer. These assays yield substantially equivalent Performance Characteristics.

Similarities:

را

. Both assays are in vitro colorimetric chemical reactions.
Both assays can be used for the quantitative analysis of total bilirubin in human . serum or plasma of adults and neonates.
. Both assays yield similar results.

Differences:

The modified ARCHITECT Total Bilirubin assay has a smaller sample size of 2.6 uL when compared to the Abbott Total Bilirubin (K060574) assay sample size of 4.0 uL.

Intended Use:

. The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma on the ARCHITECT c8000 system. · Measurement of total 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.

{5}------------------------------------------------

Performance Characteristics:

Adult Application: The Total Bilirubin assay method comparison yielded acceptable correlation between the original Total Bilirubin assay and the modified ARCHITECT Total Bilirubin assay. One hundred One hundred thirty-eight adult serum samples ranging from 0.11 to 23.96 mg/dL (based on the Total Bilirubin assay results) showed a correlation coefficient of 0.9991, slope of 0.98, and Y-intercept of 0.07 mg/dL using the ARCHITECT c8000 System.

Neonate Application: Fifty-four neonate serum samples ranging from 0.94 to 19.05 mg/dL (based on the Roche Total Bilirubin assay on the Hitachi 717 Analyzer assay results) showed a correlation coefficient of 0.9967, slope of 0.99, and Y-intercept of 0.32 mg/dL using the ARCHITECT c8000 System.

Precision studies were conducted using the Total Bilirubin assay. On the ARCHITECT c8000 System, the total %CV for Level 1 is 1.96%, Level 2 is 1.43%, Level 3 is 1.20%, and Level 4 is 1.00%. The ARCHITECT Total Bilirubin assay is linear from 0.1 to 25.0 mg/dL. The functional sensitivity (limit of quantitation) of the ARCHITECT Total Bilirubin assay is < 0.1 mg/dL and the limit of detection (LOD) 0.05 mg/dL.

These.data demonstrate the performance of the modified ARCHITECT Total Bilirubin assay is substantially equivalent to the performance of AbbottTotal Bilirubin assay.

Conclusion:

Based on analytical and clinical studies, the modified ARCHITECT Total Bilirubin assay is substantially equivalent to the performance of the AbbottTotal Bilirubin assay (k06574).

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.