The Unsaturated Iron Binding Capacity (UIBC) assay is intended to measure the unsaturated iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Device Description

Unsaturated Iron Binding Capacity (UIBC) is an in vitro diagnostic assay for the quantitative determination of the unsaturated iron binding capacity of human serum. The UIBC assay is a clinical chemistry assay in which transferrin is saturated by adding a known excess quantity of iron. The free Fe2+ reacts with Nitroso-PSAP forming a chelate compound. The color measured at 760 nm is proportional to the residual iron concentration. Unsaturated iron binding capacity is calculated by taking the iron concentration from a known excess quantity of iron.

AI/ML Overview

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

Acceptance Criteria and Device Performance

There are no explicitly stated acceptance criteria with numerical targets. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device. The performance characteristics of the new UIBC assay are compared to the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer.

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (UIBC Assay)
Correlation Coefficient	"Acceptable correlation" with predicate assay	0.9976
Slope	Similar to predicate assay	1.009
Y-intercept	Similar to predicate assay	19.863 µg/dL
Within-run %CV (Level 1)	Acceptable precision	6.9%
Within-run %CV (Level 2)	Acceptable precision	9.8%
Within-run %CV (Level 3)	Acceptable precision	3.9%
Linearity	Appropriate clinical range	Up to 805.2 ug/dL
Limit of Quantitation (Sensitivity)	Clinically relevant sensitivity	46.6 µg/dL

Study Details

The study conducted is a comparative performance study to demonstrate substantial equivalence of the new UIBC assay to a predicate device.

Sample sizes used for the test set and data provenance:
- The document does not specify the sample size used for the comparative performance study (method comparison) or the precision studies.
- The data provenance is not explicitly stated (e.g., country of origin). However, given it's an in vitro diagnostic assay, the samples would likely be human serum. The study is prospective in the sense that it involves testing the new device and comparing its performance to an existing one.
Number of experts used to establish the ground truth for the test set and their qualifications:
- This is an in vitro diagnostic assay, not an imaging or diagnostic AI device that typically relies on expert interpretation for ground truth.
- The "ground truth" for this type of assay is the result obtained from the predicate device (Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer). There were no human experts establishing ground truth in the traditional sense for the test set samples.
Adjudication method for the test set:
- Not applicable as the "ground truth" is established by the predicate device's measurement, not by expert consensus requiring adjudication.
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, a MRMC comparative effectiveness study was not done. This is an in vitro diagnostic assay, not a device involving human readers or AI assistance in interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This entire study effectively evaluates "standalone" performance, as it's an automated chemical assay. The UIBC assay measures the concentration of unsaturated iron binding capacity (UIBC) in human serum without human interpretation loops impacting the measurement itself.
The type of ground truth used:
- For the comparative performance study, the "ground truth" was the results obtained from the predicate device (Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer).
- For the precision studies, the "ground truth" was based on control material of known concentrations.
The sample size for the training set:
- The document does not mention a "training set" in the context of machine learning. This device is an in vitro diagnostic assay based on chemical reactions, not an AI/ML algorithm that requires training data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI/ML algorithm.

Summary

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JUL 30 1998

K 982041

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive

Irving, Texas 75038

Contact Person Linda Morris Senior Regulatory Specialist MS 1-6 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	June 9, 1998
Device Trade or Proprietary Name:	UIBC
Device Common/Usual Name or Classification Name:	UIBC
Classification Number/Class:	75JMO/Class I

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: _ K98904/

Test Description:

UIBC 510(k) June 9, 1998 UIBCf.lwp

Section II Page 1

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Substantial Equivalence:

The UIBC assay is substantially equivalent to the Boehringer Mannheim® UIBC assay on the Hitachi® 717 Analyzer.

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 UIBC. .
Both assays yield similar clinical results. .

Differences:

There is a minor difference in the assay range. .

Intended Use:

The Unsaturated Iron Binding Capacity (UIBC) assay is used for the quantitative determination of unsaturated iron binding capacity in serum.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ Analyzer. The UIBC assay method comparison yielded acceptable correlation with the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9976, slope = 1.009, and Y-intercept = 19.863 µg/dL. Precision studies were conducted using the UIBC assay. Within-run, between-run, and between-day studies were performed using three levels of control material. The total %CV for Level 1/Panel 113 is 6.9%, Level 2/Panel 115 is 9.8% and Level 3/Panel 116 is 3.9%. The UIBC assay is linear up to 805.2 ug/dL. The limit of quantitation (sensitivity) for the UIBC assay is 46.6 µg/dI.. These data demonstrate that the performance of the UIBC assay is substantially equivalent to the performance of the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer.

UIBC 510(k) June 9, 1998 UIBCf.lwp

Section II Page 2

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Conclusion:

: .

ﺗ ﻣﺴﻠﺴﻪ

The UIBC assay is substantially equivalent to the Boehringer Mannheim UIBC assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

UIBC 510(k) June 9, 1998
UIBCf.lwp

Section II Page 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jul 3 0 1998

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

K982041 Re : UIBC Regulatory Class: I Product Code: JMO Dated: June 9 , 1998 Received: June 10, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to We have reviewed your seccion from and we indications for market the device released above (for the indications for device is substancially equivalit (res marketed in interstate use stated in the encrosure, to as a soft ment date of the commerce prior co nay as , or to devices that have been Medical Device Amendments, or to ac-ac-visions of the Pederal reclassified in accordance with one from and therefore, Food, Drug, and Cosmecre her (1100).
market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. of the Act. The general someal registration, listing of Include roquil manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II If your device is crasbiria (Bo(Premarket Approval), it may (Special Concrolo) of Crissal controls. Bxisting major he subject co such addicionary of tound in the code of Federal Requlations, Title 21, Parts 800 to 895. ਸ rederal kegulations, freis si, ination assumes compliance with Substantly equivalence aring Practice requirements, as set the Carrent County System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Ch the GMT regaraction was publish further announcement.s action. concerning your device in the Federal Register. Please note: concerning your devres remarket notification submission does ents responde co your for you might have under sections 531 through 542 of the Act for devices under the Electronic enroagn sadiation Control provisions, or other Federal laws or requlations .

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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 yitro 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. the regulation entitled, "Misbranding by reference to
remarket notification" (21 CFR 807.97) . Other general 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 ox 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

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510(k) Number (if known):

UIBC Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 1 OR Over-The-Counter Use (Per 21 CFR 801.109)

th. Lapsala

inical Laboratory Devices 510(k) Number

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1415 Iron-binding capacity test system.

(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.