The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

Device Description

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based product containing human transferrin. The kit consists of 3 vials, each containing 1.0 mL.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator.

Please note: The provided text is a 510(k) summary for a calibrator, not a diagnostic device that performs interpretations. Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types like pathology/outcomes data) are not applicable in this context. The document focuses on demonstrating **substantial equivalence** to a predicate device, primarily through comparison of their characteristics and intended use.

Acceptance Criteria and Device Performance

For a calibrator like the Dimension Vista™ TIBC Calibrator, the "acceptance criteria" isn't typically phrased in terms of sensitivity, specificity, or accuracy against a disease state. Instead, acceptance is based on demonstrating that its performance is equivalent to a legally marketed predicate device for its intended use (calibration). The "reported device performance" is implicitly shown through the comparison table and the conclusion of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Given this context, the "acceptance criteria" can be inferred as matching the key characteristics and performance expectations of the predicate device for calibrator functionality.

Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (Dimension Vista™ TIBC Calibrator)
Intended Use: Calibrator	Calibrator (Matches)
Analyte: human transferrin	human transferrin (Matches)
Matrix: bovine albumin	bovine albumin (Matches)
Form: liquid	liquid (Matches)
Volume: ~1 mL per vial	1 mL per vial (Matches)
Levels: Provides appropriate levels for calibration	1 level (Zero by system water) - Difference noted, but deemed equivalent.
Reference Standard: NIST Iron Standard SRM 937	NIST Iron Standard SRM 937 (Matches)
Overall functionality: Effectively calibrates TIBC method on relevant system	Intended for use in the calibration of the TIBC method on the Dimension Vista™ system. (Implicitly performs this effectively, leading to substantial equivalence conclusion.)

Study Information (Based on Available Text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) submission for a calibrator, not a diagnostic device evaluating patient samples. The "test set" would refer to internal validation of the calibrator's performance against expected values, but details on sample size or provenance for such internal testing are not provided in this summary. The focus is on comparison to a predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" derived from expert consensus on patient data described for this calibrator submission. The ground truth for a calibrator relates to its chemical composition and its ability to produce expected instrument responses, which is typically validated through internal quality control and comparison to a primary standard (NIST Iron Standard SRM 937).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a "test set" of patient data is relevant here.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the calibrator's value is established by its primary standard: NIST Iron Standard SRM 937. This refers to a standard reference material from the National Institute of Standards and Technology, which provides a highly accurate and certified concentration of iron. The calibrator's assigned values are traceable to this primary standard.
The sample size for the training set
- Not Applicable. This is a calibrator, not a machine learning device that requires a training set.
How the ground truth for the training set was established
- Not Applicable. No training set is used.

Summary

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510(k) 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:	Lorraine PiestrakDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
	MAY 3 1 2006
Date of Preparation:	May 3, 2006
Name of Product:	Dimension Vista™ Total Iron Binding Capacity(TIBC) Calibrator
FDA Classification Name/Product Code:	Calibrator / JIS
Predicate Device:	Dimension® IBCT Calibrator (K994114)

Device Description:

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based product containing human transferrin. The kit consists of 3 vials, each containing 1.0 mL.

Intended use:

The TIBC Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

Comparison to Predicate Device:

	Dimension Vista™TIBC Calibrator	Dimension®IBCT Calibrator (predicate)
Intended Use	Calibrator	Calibrator
Analyte	human transferrin	human transferrin
Matrix	bovine albumin	bovine albumin
Form	liquid	liquid
Volume	1 mL per vial	1 mL per vial
Levels	1 level	3 levels
	(Zero level is system water on boardthe instrument)	(Zero level provided)
Reference	Primary standardNIST Iron Standard SRM 937	Primary standardNIST Iron Standard SRM 937

Comments on Substantial Equivalence:

Both the proposed Dade Behring Dimension Vista™ Total Iron Binding Capacity (TBC) Calibrator and the existing Dimension® IBCT calibrator are in vitro diagnostic products intended for calibrating Total Iron Binding Capacity assays.

Conclusion:

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Conclusion:

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The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is substantially equivalent to the Dimension® IBCT Calibrator based on the comparison discussed above.

Lorraine Piesta

Lorraine Piestrak Regulatory Affairs and Compliance Manager May 3, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 3 1 2006

Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manger Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101

Re: K061251

Trade/Device Name: Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: May 3, 3006 Received: May 4, 2006

Dear Ms. Piestrak:

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).

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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

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

Kd6125|

Device Name: Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator

Indications for Use:

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is intended for use in the calibration of the TIBC method on the Dimension Vista™ system.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

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

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

Carol C. Benson
Division Sign-Off

Diagnostic
and Safety
K061251

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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.