The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.

AI/ML Overview

Based on the provided text, the device is a medical calibrator, not an AI or imaging device, so many of the requested fields (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or not found in the document. The document focuses on regulatory approval based on substantial equivalence to a predicate device.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing key attributes.

Criteria (Comparison to Predicate Device)	Predicate Device (Cleared Ferritin Calibrator)	Modified Ferritin Calibrator (Reported Performance)
Intended Use	Calibrator	Calibrator
Analytes	ferritin	ferritin
Matrix	bovine albumin base	bovine albumin base
Form	lyophilized	liquid
Volume	2.0 mL per vial, reconstituted	1.0 mL per vial
Levels	5 levels	5 levels
Reference Standard	WHO standard, 2nd IS	WHO standard, 3rd IS

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

Sample Size for Test Set: Not applicable/Not provided. This is a calibrator, not a diagnostic device evaluated with patient samples. The "test" here is a comparison of product attributes against a predicate.
Data Provenance: Not applicable/Not provided in the context of patient data. The comparison is based on the characteristics of the calibrator itself.

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

Not applicable. Ground truth for patient data is not relevant for a calibrator. The "truth" in this context is the stated characteristics of the calibrator and its preparation against a WHO standard.

4. Adjudication method for the test set

Not applicable. There is no subjective interpretation or adjudication process described as this is a product comparison, not a diagnostic performance study.

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

Not applicable. This device is a calibrator for a clinical chemistry system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a calibrator, not an algorithm.

7. The type of ground truth used

For the calibrator values themselves: WHO standard (2nd IS for predicate, 3rd IS for modified device). This refers to the internationally recognized standard for ferritin. The base matrix is bovine albumin, and the ferritin is from human liver.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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KG83548

Dade Behring

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

Summary of Safety and Effectiveness Information

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.

Submitter's Name:	Cathy P. CraftDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	October 5, 1998
Name of Product:	Ferritin Calibrator
FDA Classification Name:	Calibrator
Predicate Device:	Dimension® Ferritin Calibrator, K963493

Device Description: The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.

Intended use: The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.

Comparison to Predicate Device:

Item	Cleared Ferritin Calibrator	Modified Ferritin Calibrator
Intended Use	Calibrator	Calibrator
Analytes	ferritin	ferritin
Matrix	bovine albumin base	bovine albumin base
Form	lyophilized	liquid
Volume	2.0 mL per vial, reconstituted	1.0 mL per vial
Levels	5 levels	5 levels
Reference	WHO standard, 2nd IS	WHO standard, 3rd IS

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Comments on Substantial

Equivalence: Both the cleared Ferritin Calibrator and the modified Ferritin Calibrator are intended to be used as calibrators for the Dimension® Ferritin (FERR) method.

Conclusion: The modified Ferritin Calibrator is substantially equivalent to the cleared Ferritin Calibrator based on the comparison discussed above.

Cathy P. Craft Regulatory Affairs and Compliance Manager Date: October 5, 1998

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 7 1998

Ms. Cathy P. Craft Regualtory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delware 19714-6101

K983548 Re : Trade Name: Ferritin Calibrator Requlatory Class: II Product Code: JIT Dated: October 5, 1998 Received: October 9, 1998

Dear Ms. Craft:

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 leqally 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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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Page 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known) K983548

Device Name: Ferritin Calibrator

Indications for Use:

The Ferritin Calibrator is intended to be used to calibrate the Ferritin (FERR) Method on the Dimension® RxL clinical chemistry system.

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Cathy P. Craft Regulatory Affairs and Compliance Manager

October 5, 1998

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division	Medical Laboratory Devices
510(k) Number	KG8354

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Over-The-Counter Use

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.