The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Device Description

The ARCHITECT Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma (lithium heparin or tripotassium EDTA). The ARCHITECT Ferritin assay is calibrated with Abbott ARCHITECT Ferritin Calibrators. Abbott Ferritin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study details for the Abbott ARCHITECT™ Ferritin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Correlation Coefficient (Least Squares)	0.986 (against AxSYM® Ferritin)
Slope (Least Squares)	1.18 (95% CI of 1.17 to 1.20)
Intercept (Least Squares)	-3.65 ng/mL (95% CI of -14.53 to 7.24)
Correlation Coefficient (Passing-Bablok)	0.986 (against AxSYM® Ferritin)
Slope (Passing-Bablok)	1.17 (95% CI of 1.16 to 1.19)
Intercept (Passing-Bablok)	-1.89 ng/mL (95% CI of -2.64 to -1.23)
Quantitative Range Tested	1 to 2000 ng/mL

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

Sample Size: 518 specimens
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The text only mentions "human serum and plasma."

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

Not Applicable. The study is a method comparison study comparing the performance of a new device (ARCHITECT Ferritin) against a legally marketed predicate device (AxSYM® Ferritin), not a study establishing ground truth based on expert review.

4. Adjudication Method for the Test Set:

Not Applicable. As this is a method comparison study, there is no adjudication process involving human experts to establish a "ground truth" for each case. The comparison is directly between the measurements of the two devices.

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:

No. This is not an MRMC study. The device is an in vitro diagnostic assay, not an imaging or diagnostic AI tool that assists human readers.

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

Yes. This study primarily evaluates the standalone performance of the ARCHITECT Ferritin assay by comparing its quantitative measurements directly against those obtained from the predicate AxSYM® Ferritin assay. There is no human-in-the-loop component described for the measurement process itself.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the measurements provided by the legally marketed predicate device, AxSYM® Ferritin assay. This is a common approach for demonstrating substantial equivalence for assays, where a new device's performance is shown to be comparable to an already approved device.

8. The Sample Size for the Training Set:

Not Applicable. This is a method comparison study for an in vitro diagnostic assay, not a machine learning model that requires a training set. The term "training set" is not relevant here.

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

Not Applicable. (As per point 8).

Summary

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510(k) Summarv

Abbott ARCHITECT™ Ferritin

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Ferritin constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the ARCHITECT Ferritin assay and the AxSYM® Ferritin assay. The intended use of both assays is for the quantitative determination of ferritin in human serum and plasma. A least squares linear regression analysis between these two assays, using 518 specimens, over the range of 1 to 2000 ng/mL, yielded a correlation coefficient of 0.986, a slope of 1.18, (95% Confidence Interval [CI] of 1.17 to 1.20), and an intercept of -3.65 ng/mL (95% CI of -14.53 to 7.24). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.986, a slope of 1.17, (95% CI of 1.16 to 1.19), and an intercept of -1.89 ng/mL (95% CI of -2.64 to -1.23).

In conclusion, these data demonstrate that the ARCHITECT Ferritin assay is as safe and effective as, and is substantially equivalent to, the AxSYM Ferritin assay.

Prepared and Submitted October 23, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092

Abbott Laboratories ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064-3537

ARCHITECT Ferritin 510(k) October, 1998 er510k.do

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 7 1998

Laura L. Granitz Sr. Regulatory Specialist Dept. 9V6 Bldg. AP31 ABBOTT LABORATORIES 200 Abbott Park Road Abbott Park, IL 60064-3537

K983759 Re: Trade Name: Abbott ARCHITECT™ Ferritin Regulatory Class: II Product Code: DBF October 23, 1998 Dated: October 26, 1998 Received:

Dear Ms. Granitz:

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 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 Regulations, 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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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in four of your device to a legally marketed predicate device equivalence or possification 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 regaration (br on. . please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and 594 4500. Indiations 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 Sutman

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): $983751 Device Name: Abbott ARCHITECT™ Ferritin Indications For Use:

The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

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

Concurrence of CDRH/Office of Device Evaluation (QDE),

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983759

Prescription Use √
OR
Over-The-Counter Use _

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.5340 Ferritin immunological test system.

(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).