The Iron assay is used for the quantitation of iron in human serum on the ALCYON 300/300i Analyzer. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Device Description

Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott Laboratories Iron assay:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Method Correlation	Acceptable correlation to predicate device	Correlation coefficient (r) = 0.9835, Slope = 0.929, Y-intercept = -0.385 ug/dL
Precision (Total %CV)	Acceptable %CV	Level 1/Panel 111: 2.7%
		Level 2/Panel 112: 5.5%
Linearity (Upper Limit)	Acceptable upper limit	Up to 1,400 ug/dL
Limit of Quantitation (Sensitivity)	Acceptable sensitivity	10 ug/dL

Explanation of Implied Acceptance Criteria: The document doesn't explicitly state numerical acceptance criteria for each metric. Instead, it uses phrases like "acceptable correlation" and "These data demonstrate that the performance of the Iron assay is substantially equivalent." This implies that the reported performance values were deemed sufficient to demonstrate substantial equivalence to the predicate device (Raichem Serum Iron assay). For a quantitative test like this, acceptance limits would typically be based on established clinical chemistry guidelines and comparison to the predicate's known performance for method correlation, precision, and linearity.

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

Sample Size for Test Set: The document explicitly states "Comparative performance studies were conducted using the ALCYON™ Analyzer." However, it does not specify the sample size used for these comparative studies (e.g., how many patient samples were tested).
Data Provenance: The document does not provide information regarding the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the studies were conducted using the ALCYON™ Analyzer.

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

This information is not applicable to this type of device. The Abbott Iron assay is a clinical chemistry assay for quantitative determination of iron in human serum. Its "ground truth" is established by comparing its performance against a legally marketed predicate device (Raichem Serum Iron assay) using patient samples, not by expert interpretation of images or other subjective data. No human experts are used to establish a "ground truth" for the measured iron levels in this context.

4. Adjudication Method for the Test Set

This information is not applicable to this device. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective assessments, such as radiology interpretations or clinical diagnoses. For a quantitative chemical assay, the comparison is directly between the numerical results of the new device and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported. This type of study typically involves multiple human readers interpreting cases with and without AI assistance to measure the impact of AI on reader performance. The Abbott Iron assay is an automated in vitro diagnostic test, not an AI-assisted diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The entire performance characterization (method correlation, precision, linearity, sensitivity) described in the document is a standalone performance assessment of the Abbott Iron assay running on the ALCYON™ Analyzer. There is no human-in-the-loop component for the measurement or result generation itself; the device processes samples and provides quantitative results. The comparison is between the new device's results and those of a predicate device.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the results obtained from the legally marketed predicate device, the Raichem® Serum Iron assay on the Roche® Cobas Mira® Plus Automated Chemistry System. The study establishes substantial equivalence by demonstrating that the new device's measurements align well with the predicate device's measurements.

8. Sample Size for the Training Set

The document does not provide any information about a training set. This is consistent with a traditional chemical assay development and validation process, which typically does not involve machine learning models that require a distinct training set in the way AI/ML algorithms do. The development likely involved calibration and optimization steps, but these are distinct from "training a model" in the AI sense.

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

As no training set is mentioned or applicable in the context of this traditional clinical chemistry assay, the method for establishing its ground truth is not applicable.

Summary

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ADD CLIN CHEM

CONFILICATIA

2981241

1 1698 MAY

510(k) Summary

Fax (972) 753-3367

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

Date of Preparation of this Summary:	April 03, 1998
Device Trade or Proprietary Name:	Iron
Device Common/Usual Name or Classification Name:	Iron
Classification Number/Class:	75CFM/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:

Substantial Equivalence:

The Iron assay is substantially equivalent to the Raichem® Serum Iron assay (K864819) on the Roche® Cobas Mira® Plus Automated Chemistry System.

Iron 510(k) April 23, 1998 IronfE2a.lwp .

Section II Page 1

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Both assay yield similar Performance Characteristics.

Similarities:

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

Differences:

There is a difference between the assay range. .

Intended Use:

The Iron assay is used for the quantitation of iron in human serum ALCYON 300/300i Analyzer.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Iron assay method comparison yielded acceptable correlation with the Raichem Serum Iron assay on the Roche Cobas Mira Plus Automated Chemistry System. The correlation coefficient = 0.9835, slope = 0.929, and Y-intercept = - 0.385 ug/dL. Precision studies were conducted using the Iron 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 2.7% and Level 2/Panel 112 is 5.5%. The Iron assay is linear up to 1,400 ug/dL. The limit of quantitation (sensitivity) of the Iron assay is 10 ug/dL. These data demonstrate that the performance of the Iron assay is substantially equivalent to the performance of the Raichem Serum Iron assay on the Roche Cobas Mira Plus Automated Chemistry System.

Conclusion:

The Iron assay is substantially equivalent to the Raichem Serum Iron assay on the Roche Cobas Mira Plus Automated Chemistry System as demonstrated by results obtained in the studies.

Iron 510(k) April 23, 1998 IronfE2a Iwp

Section II Page 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 1998 MAY

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

K981241 Re : Iron Requlatory Class: I Product Code: JIY Dated: April 3, 1998 Received: April 6, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਮੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as setforth 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

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

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CONFIDENTIAL

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________ Iron

Indications For Use:

(Division Sign-Off) Division of Clinical Laborato 510(k) Number .

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

Concyfrence 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

§ 862.1410 Iron (non-heme) test system.

(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(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.