The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three levels.

AI/ML Overview

Here's an analysis of the provided text regarding the Dimension® Iron Calibrator and its performance:

1. Acceptance Criteria and Reported Device Performance

The document describes the stability and traceability of the Dimension® Iron Calibrator (IRON Cal - DC 85). However, the specific quantitative acceptance criteria for performance (e.g., recovery percentages, maximum allowable drift) are not explicitly stated in a table format within the provided text. The document focuses on the methods used to assess stability and traceability, rather than specific results against pre-defined thresholds.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied or described)	Reported Device Performance
Stability	Target shelf life: 12 months. Requires 13 months of real-time testing on three lots. Calibrator drift must be dissociable from analytical system drift (by comparing 4°C vs. -20°C storage).	"Studies require 13 months of real time testing on three lots of product." (No explicit pass/fail result stated, but implies the study was conducted to support the 12-month shelf life).
Traceability	Assigned values are standardized to NIST SRM 937.	"The assigned values of the IRON calibrator are standardized to NIST SRM 937..." (This describes the method of traceability, not a performance metric like a correlation coefficient or recovery percentage against the standard).
Value Assignment	New calibrator lot must have acceptable recovery versus the Reference Lot (NIST SRM 937) and a Control Calibrator Lot.	"The new calibrator lot must have acceptable recovery verses the Reference Lot and a Control Calibrator Lot..." (This describes the process for value assignment, not specific recovery results that met a defined "acceptable" criterion).

2. Sample Size for Test Set and Data Provenance

Test Set Sample Size: For stability studies, "three lots of product" were used. For traceability and value assignment, it mentions "six working Iron Standard Solutions of NIST SRM 937" for assigning values, and the comparison of "new calibrator lot" against "Reference Lot" and "Control Calibrator Lot." The number of individual samples or measurements within these lots/solutions is not specified.
Data Provenance: The data is generated internally by Dade Behring Inc. (the applicant). It is prospective data, as it describes studies conducted to support the device's claims (e.g., 13 months of real-time stability testing). The country of origin of the data is implicitly the United States, where Dade Behring Inc. is located.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not mention any human experts being used to establish ground truth for the performance studies of this calibrator device. The ground truth for a calibrator is typically established through a highly controlled and standardized reference material.

4. Adjudication Method for the Test Set

Since no human experts are mentioned for establishing ground truth, there is no adjudication method described or applicable in this context.

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

An MRMC study is not applicable to this device. This is an in vitro diagnostic calibrator, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, no comparison of human readers with or without AI assistance was performed.

6. Standalone Performance Study

Yes, the studies described, particularly the stability studies and the traceability/value assignment studies, can be considered standalone performance studies for the calibrator device itself. These studies evaluate the calibrator's inherent properties (stability over time, accuracy of assigned values against a gold standard) independent of a human operator's interpretation. The calibrator's function is to provide a known reference point for the Dimension® clinical chemistry system, so its "performance" is evaluated on its ability to maintain that reference.

7. Type of Ground Truth Used

The primary ground truth used for this calibrator is NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material). This is a highly certified and recognized reference material, considered a "gold standard" for iron concentration.

8. Sample Size for the Training Set

This document describes a calibrator, not a machine learning model. Therefore, the concept of a "training set" in the context of AI or algorithms is not applicable. The calibrator itself does not learn from data; its values are assigned based on comparisons to a reference standard.

9. How Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the AI/machine learning sense for this device. The values of the calibrator are established through direct comparison and standardization against the NIST SRM 937, which is intrinsically the ground truth for iron concentration. The process involves:

Preparing six working Iron Standard Solutions from NIST SRM 937.
Assigning values to new lots of the calibrator by recovering these reference solutions.
Ensuring acceptable recovery against the NIST SRM 937 (Reference Lot) and an approved Control Calibrator Lot.

Summary

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2006 MAR 9

510(k) Summary for the Dimension® Iron Calibrator (IRON Cal - DC 85)

长060266 A. 510(k) Number:

B. Analyte: Iron Calibrator
C. Type of Test: Calibrator Material

D. Applicant:

Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager (302) 631-9454

Date of Preparation: January 30, 2006

E. Proprietary and Established Names: Dimension® Iron Calibrator (IRON Calibrator- DC 85)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 -- CALIBRATOR
1. Classification: Class II
1. Product Code: JIS CALIBRATORS, PRIMARY
1. Panel: CLINICAL CHEMISTRY

G. Intended Use:

l . Intended use(s):
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
1. Indication(s) for use:
  The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.

This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

1. Special condition for use statement(s): none
1. Special instrument Requirements: none

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H. Device Description:

The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three levels.

. Substantial Equivalence Information:

1. Predicate Device: Dimension® IRN/TIBC Calibrator (DC21)

2. Predicate K Number(s): K944093

3. Comparison with Predicate:

Similarities
Item	Device	Predicate
Intended Use	To calibrate the iron method for theDimension® clinical chemistrysystem.	same
Traceability	NIST SRM 937 (NIST SRM: NationalInstitute of Standards andTechnology- Standard ReferenceMaterial)	same
Matrix	Aqueous solution of iron wiredissolved in a dilute solution of HCl	same
Number ofLevels	3	same
Differences
Item	Device	Predicate
TargetConcentrations	0, 50, 1075 ug/dL	50, 500 1000ug/dL

J. Standard/Guidance Document Referenced:

Guidance;

Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999

Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004

Standards: Continuous Quality Improvement Essential Management Approaches GP22-A Stability testing of In-Vitro Diagnostic Devices CEN 13640

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Medical devices -Application of risk management to medical devices ISO 14971:2000 Medical devices -- Symbols to be used with medical device labeling ISO 15223 and information to be supplied

K. Test Principle:

The Dimension® Iron Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® IRON (Cat # DF85) method for the Dimension® clinical chemistry system.

L. Performance Characteristics:

Stability

Target shelf life for the Dimension® IRON Calibrator is 12 months. Studies require 13 months of real time testing on three lots of product. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with product stored at -20℃ to ensure that analytical system drift is dissociated with calibrator drift.

2. Traceability:

The assigned values of the IRON calibrator are standardized to NIST SRM 937 (NIST SRM: National Institute of Standards and Technology- Standard Reference Material). Six working Iron Standard Solutions of NIST SRM 937 (0, 25, 50, 75, 500, 1075 µg/dL) are prepared and used to assign each new lot of calibrator.

3. Value Assignment

The new calibrator levels are made by adding acid dissolved NIST 837 into base matrix. The new calibrator lots are assigned verses the six working standard solutions prepared from NIST SRM 937(Reference Lot). The new calibrator lot must have acceptable recovery verses the Reference Lot and a Control Calibrator Lot (Control Calibrator Lot = Any Approved Calibrator Lot).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

2006 MAR 9

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Ms. Andrea M. Tasker Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community P.O. Box 6101, Building 500, M/S 514 Newark, DE 19714-6101

Re: K060266

Trade/Device Name: Dimension® IRON Calibrator (IRON Cal- DC85) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: January 30, 2006 Received: February 1, 2006

Dear Ms. Tasker:

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. Iisting 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).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 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 (240) 276-0484. 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/industry/support/index.html,

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number (if known):

Device Name:

Dimension® IRON Calibrator (IRON Cal- DC85)

Indications for Use:

The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.

Prescription Use 11 (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-counter Use (21 CFR 801 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

313(x) K070266

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.