Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.

The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.

Device Description

The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.

The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.

AI/ML Overview

The provided text describes the 510(k) summary for the "quantex Ferritin" device. This is an in vitro diagnostic (IVD) device, not a an Artificial Intelligence/Machine Learning (AI/ML) device that typically involves the concepts of ground truth, experts, and training/test sets in the same way.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not directly applicable or are not detailed in the context of this type of traditional IVD submission. The provided document focuses on establishing substantial equivalence to a predicate device through performance data, primarily method comparison and precision, rather than validating an AI algorithm.

However, I can extract the available information and present it in the requested format, noting where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Method Comparison	Substantial equivalence to predicate Axios Ferritin for quantitative ferritin determination. (Implied: High correlation and acceptable bias.)	94 serum samples (3.2 to 1000 ng/ml). Slope: 0.92, Correlation Coefficient (r): 0.994 (vs. predicate device).
Precision (Within-Run)	Acceptable coefficient of variation (CV) for consistent results.	CV: 4.1% (at mean 43.2 ng/mL) and 1.6% (at mean 402.8 ng/mL) using quantex Ferritin controls I/II.
Intended Use	Aid in diagnosis of diseases affecting iron metabolism (hemochromatosis, iron deficiency anemia).	Met (stated as substantially equivalent to predicate).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 94 serum samples.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is common for traditional IVD submissions which often use internal lab studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For an IVD device measuring a biomarker (ferritin), "ground truth" is typically established by comparative measurement against a reference method or predicate device, not by expert interpretation in the way it's used for AI/ML image analysis. The "ground truth" here is the measurement obtained from the predicate device.

4. Adjudication method for the test set

Not Applicable. This concept is for resolving discrepancies among expert readers, which is not relevant for this IVD device's validation.

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 AI/ML device, and no MRMC study was conducted or is relevant for this type of IVD.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device (quantex Ferritin) is a standalone diagnostic test performed on a Clinical Chemistry System. Its performance is reported for the assay itself, without human interpretation as the primary output. However, it's not an "algorithm" in the AI sense.

7. The type of ground truth used

Comparative Measurement: The "ground truth" for the method comparison study was the results obtained from the predicate device, AxSYM Ferritin.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set in the AI sense.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set.

Summary

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

K040879

MAY 1 0 2004

Section 3 quantex Ferritin 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

April 2, 2004

Name of the device:

quantex Ferritin

Classification name(s):

866.5340	Ferritin Immunological Test System
DBF	Ferritin, Antigen, Antiserum, Control

Class II

Identification of predicate device(s):

K935847 AxSYM Ferritin

Description of the device/intended use(s):

The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.

The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

Quantex Ferritin is substantially equivalent to the commercially available predicate device, AxSYM Ferritin, in performance and intended use.

Summary of Performance Data:

In a method comparison study evaluating 94 serum samples with Ferritin levels ranging from 3.2 to 1000 ng/ml on an ILab 900/1800, the slope was 0.92 and the correlation coefficient (r) was 0.994 for quantex Ferritin versus the predicate device.

Within precision assessed over multiple runs using quantex Ferritin controls VII on an Lab 900/1800 gave a CV of 4.1% (at a mean of 43.2 ng/mL) and 1.6% (at a mean of 402.8 ng/mL).

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 0 2004

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

K040879 Re:

Trade/Device Name: Quantex Ferritin Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, JJX, JIT Dated: May 03, 2004 Received: May 04, 2004

Dear Ms. Marble:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

Page 2

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Joseph L. Ardolett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: quantex Ferritin

Indications for Use:

The quantex Ferritin controls VII are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.

The quantex Ferritin standard multipoint is intended for use in establishing the calloration curve for the quantex Ferritin reagents by turbidimetry.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Marie Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO40879 510(k) _______________________________________________________________________________________________________________________________________________________________________

Section 2

quantex Ferritin 510(k)

Page 1 of 1

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).