OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.

Device Description

OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision
Intra-assay %CV	(Not explicitly stated, but typically <10%)	5.5% to 7.00%
Inter-assay %CV	(Not explicitly stated, but typically <10%)	4.60% to 9.00%
Accuracy by Recovery	Recovery close to 100% (e.g., 90-110%)	89% to 101%
Accuracy by Correlation	High correlation coefficient (e.g., >0.95), slope close to 1, intercept close to 0 when compared to a legally marketed predicate device.	Correlation coefficient: 0.98 Slope: 0.92 Y-intercept: 11.95

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. Instead, it reports the performance characteristics, implying that these values met internal or regulatory expectations for substantial equivalence to the predicate device (Abbott IMX Ferritin).

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

Sample Size for Test Set:
- Precision (Intra-assay): 3 levels of control material, 20 replicates each.
- Precision (Inter-assay): 3 levels of control material, duplicate assays over 5 days (total 20 replicates).
- Accuracy by Recovery: Not explicitly stated, but “different levels of ferritin” in pooled human serum, assayed in triplicate.
- Accuracy by Correlation: 70 serum samples.
Data Provenance: Not explicitly stated. Likely retrospective clinical samples or laboratory-prepared samples (e.g., spiked samples for recovery). The country of origin is not mentioned, but given the manufacturer's location (Westwood, MA, USA), it's highly probable the data is from the USA.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not Applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker. The "ground truth" for such devices is typically established through reference methods, certified standards, or comparison to a legally marketed predicate device, rather than expert consensus on interpretation. The document describes comparison to a commercially available Ferritin assay (the Abbott IMX Ferritin) as the reference for accuracy.

4. Adjudication Method (Test Set):

Not Applicable. As noted above, adjudication by experts for interpretation is not relevant for this type of quantitative IVD device.

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

No. This is an automated in vitro diagnostic (IVD) device. MRMC studies are typically for image-based diagnostic systems where human readers interpret results, and the AI's effect on their performance is being evaluated. This device provides a quantitative measurement, not an interpretation that human readers would perform.

6. Standalone (Algorithm Only) Performance:

Yes. The reported performance characteristics (Precision, Accuracy by Recovery, Accuracy by Correlation) are all measures of the OPUS Ferritin assay's performance by itself or in direct comparison to another assay, without human intervention in the result determination. The device's output is a quantitative ferritin value.

7. Type of Ground Truth Used:

(For Accuracy by Correlation): Results from a commercially available, legally marketed Ferritin assay (Abbott IMX Ferritin). This serves as the comparative "ground truth" for evaluating substantial equivalence.
For Precision: Based on the inherent variability within the assay when measuring control materials.
For Accuracy by Recovery: Based on the known amount of ferritin spiked into samples.

8. Sample Size for the Training Set:

Not explicitly stated/Not Applicable in the traditional sense. For an immunoassay like this, the "training" isn't typically based on a large dataset in the way a machine learning algorithm is trained. Instead, the assay's development involves:
- Assay Optimization: Iterative laboratory experiments to determine optimal reagent concentrations, incubation times, etc. This doesn't involve a distinct "training set" of patient samples in the same way an AI model would.
- Calibrator Definition: The six-level calibrator system is established with known concentrations to define the assay's standard curve for quantitative measurement.

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

Not applicable in the traditional sense of a "training set" for an AI algorithm.
- The "ground truth" for the calibrators would be established by preparing solutions with precisely known concentrations of ferritin, using highly purified ferritin standards. These standards would be traceable to recognized reference materials if available.
- The overall functionality of the immunoassay system (reagents, instrument) is developed and optimized as described in point 8, through biochemical and analytical testing, rather than "ground truth" labels on a dataset.

Summary

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K973202
Sept. 12, 1997

Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification

510(k) Summary for OPUS Ferritin

Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:

Manufacturer:

Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt

Preparation date:

July 7, 1997

2 . Classification: Device Name/

Ferritin Test System OPUS Ferritin: Classification Number: Class II (866.5340).

3 . ldentification of the legally marketed device:

IMX® Ferritin

4 . Proposed Device Description:

OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.

5 . Proposed Device Intended Use:

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Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification

Medical device to which equivalence is claimed and comparison 6. information:

The OPUS Serum Ferritin assay is substantially equivalent in intended use to results obtained using the Abbott IMX Ferritin. The Abbot IMX Ferritin, like the proposed product, employs the principle of two site or sandwich immunoassay. Both methods use a labeled antibody for the quantitative measurement of ferritin in human serum. The OPUS Serum Ferritin and Abbott IMX Ferritin are both based on a six level calibrator system. Also, both the Abbott IMX Ferritin and the OPUS Serum Ferritin assay include a tri-level control.

The OPUS Serum Ferritin differs from the Abbott IMX Ferritin in that human serum and plasma samples may be used in the Abbott IMX Ferritin and only human serum in the OPUS Serum Ferritin assay.

7. Device Performance Characteristics:

Precision

Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.5% to 7.00%.

Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.60% to 9.00%.

Accuracy by Recovery

Recovery was determined by spiking previously assaved and pooled human serum matrix with different levels of ferritin. The samples were assaved using OPUS Ferritin in triplicate. Percent recovery ranged from 89 to 101%.

Accuracy by Correlation

OPUS Ferritin was compared to a commercially available Ferritin assay by evaluation of 70 serum samples ranging from 2.31 to 807.00 ng/ml. A correlation coefficient of 0.98 was obtained, with a v-intercept value of 11.95 and a slope of 0.92.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling an eagle or bird in flight, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the top portion of the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 2 1997

Ms. Ruth Forstadt Regulatory Affairs Associate Behring Diagnostics Inc. 151 University Avenue Westwood, Massachusetts 02090

Re : K973202 OPUS® Serum Ferritin Trade Name: Product Code: Regulatory Class: II DBF JMJ II Dated: July 7, 1997 Received: July 8, 1997

Dear Ms. Forstadt:

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 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 requirement, 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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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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Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification

Page of

510(k) Number (if known): K973302

Device Name:

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OPUS Ferritin Test System

Indications For Use:

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Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use

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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).