The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Device Description

Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum. The TIBC assay is a clinical chemistry assay which involves a sample pretreatment followed by the analysis of TIBC with the Iron reagents. Ferric chloride saturating solution is mixed with the sample to bind all available apotransferrin binding sites with iron. Alumina adsorbent removes excess iron from the mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution by the saturating solution.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the TIBC assay, detailing acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are established by demonstrating substantial equivalence to the predicate device, the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System. The primary performance metrics used for comparison are correlation coefficient, slope, and Y-intercept from a method comparison study, along with precision and linearity data.

Acceptance Criteria / Performance Metric	Reported Device Performance (TIBC assay)
Method Comparison (vs. A-GENT® TIBC assay)
Correlation Coefficient	0.9896
Slope	0.988
Y-intercept	6.790 ug/dL
Precision (Total %CV)
Level 1/Panel 111	2.1%
Level 2/Panel 112	4.3%
Linearity (Iron assay)	Up to 1778.5 ug/dL
Limit of Quantitation (Sensitivity - Iron assay)	3.8 ug/dL
Calculated TIBC values acceptability range	11.4 ug/dL to 5335.5 ug/dL

The document states that "These data demonstrate that the performance of the TIBC assay is substantially equivalent to the performance of the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System." This implies that the reported performance metrics met the internal acceptance thresholds for substantial equivalence to the predicate.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided summary for the method comparison or precision studies.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The studies were "conducted using the AEROSET™ Analyzer."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker (TIBC). The "ground truth" for the test set would be the results obtained from the predicate device (A-GENT® TIBC assay), which is itself a laboratory assay. Expert consensus or human reader interpretation is not typically involved in establishing ground truth for such quantitative chemical assays.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. As an IVD assay comparing results against a predicate assay, there is no human adjudication process involved in generating or confirming the reference values.
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 MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or clinical decision support tool that is interpreted by human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics provided (correlation, precision, linearity, sensitivity) represent the standalone performance of the TIBC assay on the AEROSET™ Analyzer. This is typical for IVD submissions, where the assay itself is the "algorithm" and its performance is evaluated directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Predicate Device Results: The "ground truth" for the comparative performance study was the quantitative results obtained from the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System. This is a common and accepted method for establishing substantial equivalence for new IVD assays.
The sample size for the training set:
- Not applicable/Not mentioned. This device is a traditional chemical assay, not an AI/machine learning model that requires a training set in the conventional sense. The "development" of the assay involves optimization of reagents and procedures, not a data-driven training process with labeled data.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K98 1654

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Jul 22 1998

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 8, 1998
Device Trade or Proprietary Name:	TIBC
Device Common/Usual Name or Classification Name:	TIBC
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: _______________________________________________________________________________________________________________________________________________

Test Description:

TIBC 5100k Mav 8, 1998 TIBCf.JWD

Section II Page 1

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Substantial Equivalence:

The TIBC assay is substantially equivalent to the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System.

Both assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for sample pretreatment in the quantitative determination . of TIBC.
Both assays yield similar clinical results. .

Differences:

There is a difference in the assay range. .

Intended Use:

The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ Analyzer. The TIBC assay method comparison yielded acceptable correlation with the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System. The correlation coefficient = 0.9896, slope = 0.988, and Y-intercept = 6.790 ug/dL. Precision studies were conducted using the TIBC 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 2.1% and 4.3% for Level 2/Panel 112. The Iron assay is linear up to 1778.5 us/dL. The limit of quantitation (sensitivity) for the Iron assay is 3.8 ug/dL. The calculated TIBC values are acceptable from 11.4 ug/dL to 5335.5 ug/dL. These data demonstrate that the performance of the TIBC assay is substantially equivalent to

Section II Page 2

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the performance of the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System.

Conclusion:

The TIBC assay is substantially equivalent to the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System as demonstrated by results obtained in the studies.

IBC 510ck May 8 1998

Section II Page 3

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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

JUL 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark Littlefield Section Manager, Requlatory Affairs ABBOTT LABORATORIES 1920 Hurd Drive Irving, TX 75038

Re : K981654 TIBC Trade Name: Regulatory Class: I Product Code: JMO Dated: May 8, 1998 Received: May 11, 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 device is substantially equivalent (for the indications for use stated in the enclosure) 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, Druq, 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 requlations 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 requirement, as set forth in the Quality System Requlation (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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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): 198165 Y

TIBC Device Name: ____________________

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 981654

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 11 OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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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.