The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

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

Device Description

The Dimension Vista™ IRON Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension Vista ™ system for the quantitative determination of iron in serum and plasma.

The Dimension Vista™ Iron Calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit contains three glass screw top vials, 1.0 mL each, of the Calibrator A (1075 ug/dL).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Dimension Vista™ IRON Flex® reagent cartridge and Calibrator, based on the provided document:

This document is a 510(k) summary for an in vitro diagnostic device and its calibrator. For such devices, acceptance criteria typically relate to performance characteristics like precision, accuracy (comparison to a predicate device or reference method), linearity, and interference. The study described is primarily a comparative study to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for performance metrics. Instead, it states that "The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ IRON Flex® reagent cartridge is substantially equivalent to the designated predicate device."

However, the comparison table between the device and predicate for the reagent cartridge (Section I.3) highlights similarities in performance-related parameters which imply the new device is expected to meet similar performance standards to the predicate. The stated "Assay Range: 0 to 1,000 µg/dL" is a key performance metric.

For the calibrator, similar qualitative substantial equivalence is claimed without specific quantitative acceptance criteria or performance metrics beyond its intended use for calibrating the IRON method.

Therefore, a table cannot be fully generated with explicit acceptance criteria as they are not quantitatively stated in the document. However, we can infer performance characteristics from the comparison to the predicate.

Inferred Performance Characteristics (from comparison to predicate):

Performance Metric	Acceptance Criteria (Implicit/Inferred)	Reported Device Performance
For Reagent Cartridge:
Measurement Method	Bi-chromatic endpoint measurement (600 and 700 nm)	Bi-chromatic endpoint measurement (600 and 700 nm)
Calibration Type	Linear calibration	Linear calibration
Assay Range	0 to 1,000 µg/dL (same as predicate)	0 to 1,000 µg/dL
Sample Types	Serum and Heparin plasma (same as predicate)	Serum and Heparin plasma
Standardization	NIST SRM 937 (same as predicate)	NIST SRM 937
For Calibrator:
Intended Use	To calibrate the iron method (same as predicate)	To calibrate the iron method
Traceability	NIST SRM 937 (same as predicate)	NIST SRM 937
Matrix	Aqueous solution of iron wire dissolved in dilute HCl (same as predicate)	Aqueous solution of iron wire dissolved in dilute HCl

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance testing according to the verification and validation test protocols." The guidance documents referenced (e.g., NCCLS EP7-A for interference, EP5-A2 for precision, EP09-A2 for method comparison) suggest standardized sample sizes and methodologies for specific tests, but the actual numbers used in this specific submission are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of in vitro diagnostic device (IVD). Ground truth for IVDs like this is established through comparison to a well-characterized predicate device or reference methods, not human expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation or diagnostic decisions are being evaluated, such as in imaging studies. For an IVD measuring a chemical analyte, the "ground truth" is determined by the reference method or predicate device's measurement, not by expert consensus or adjudication.

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. MRMC studies are used to evaluate human reader performance, often with or without AI assistance, in diagnostic imaging or similar fields. This document concerns an in vitro diagnostic reagent cartridge for measuring an analyte, not an AI-assisted diagnostic tool for human readers.

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

This device is a standalone instrument-based measurement system. Its performance is evaluated intrinsically through analytical studies (precision, accuracy, linearity, interference) against established analytical methods and a predicate device. The performance is the "algorithm only" in the sense that it is the device's ability to accurately measure iron without human interpretation beyond operating the instrument and reading the numerical result.

7. The Type of Ground Truth Used

For the Dimension Vista™ IRON Flex® reagent cartridge, the primary type of "ground truth" or reference for establishing performance and substantial equivalence is:

Comparison to a legally marketed predicate device: Dimension® Iron Flex® reagent cartridge (K060264).
Reference materials/methods: The device's standardization is traceable to NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material), which serves as a highly accurate reference for iron concentration.
Established analytical principles: The method adapts direct iron assays using Ferene® chromophore, a recognized chemical principle for iron measurement.

For the Dimension Vista™ IRON Calibrator, the ground truth for its value and performance is primarily NIST SRM 937 traceability and its ability to properly calibrate the iron method on the Dimension Vista™ system, aligning with the predicate calibrator.

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic reagent and calibrator kit. It does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical measurements, with an analytical curve (likely established through instrument calibration and validation runs, not machine learning) guiding its quantitative output.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of machine learning for this device. The accuracy of measurements is established via traceability to NIST SRM 937 and comparison to the predicate device, following established laboratory quality control and validation procedures.

Summary

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K061793

AUG - 7 2006

510(k) Summary for the Dimension Vista™ IRON Flex® reagent cartridge

A. 510(k) Number:

B. Analyte: Total iron
C. Type of Test: Quantitative

D. Applicant:

Manufacturer: 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: June 23, 2006

E. Proprietary and Established Names:

Dimension Vista™ IRON Flex® reagent cartridge

F. Regulatory Information:

l . Regulation section: 21 CFR §862.1410 Iron (non-heme) test system
Classification: Class I 2.
1. Product Code: JIY
Panel: Chemistry (75) 4.

G. Intended Use:

Intended for Use:

The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma.

2. Indications for Use:

1. Special condition for use statement(s): none
1. Special instrument Requirements: Dimension Vista ™ system

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H. Device Description:

I. Substantial Equivalence Information:

Predicate Device: Dimension® Iron Flex® reagent cartridge (IRON- DF85)

1. Predicate K Number(s): K060264

Similarities
Item	Device	Predicate
Intended Use	Quantitative determination of total iron	same
Reagent components	Ferene® (chromophore)Thiourea (prevent Cu interference)Ascorbic acid (reducing agent)	same
Measurement method	Bi-chromatic endpoint measurement (600 and 700 nm)	same
Calibration	linear calibration	same
Assay Range	0 to 1,000 μg/dL	same
Sample Types	Serum and Heparin plasma	same
Standardization	NIST SRM 937	same
Differences
Item	Device	Predicate
Sample Volume	20uL	40uL

3. Comparison with Predicate:

J. Standard/Guidance Document Referenced

Guidance;

Calibration Scheme

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

3 levels in triplicate

A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications

2 levels in duplicate

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff

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2. Standards:

Medical Devices - Symbols to be used with medical device labeling and information to be supplied (15223). General, ISO

Medical devices - Application of risk management to medical devices (14971:2000) General, ISO Stability Testing of In Vitro Diagnostic Reagents (13640), InVitro, CEN

Continuous Quality Improvement: Essential Management Approaches: Approved Guideline (GP 22-A). InVitro, NCCLS

Interference Testing in Clinical Chemistry; Approved Guideline (EP 7-A), InVitro, NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP5-A2), InVitro, CLSI

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP09-A2), InVitro, NCCLS

K. Test Principle:

The automated Dimension Vista™ IRON method is an adaptation of direct iron assays using the chromophore Ferene ® . Under acidic conditions, iron (Fe+++) bound to the protein transferrin is released. In the presence of the reducing agent ascorbic acid, (Fe+++) is reduced to (Fe++). (Fe ++) forms a blue complex with 3-(2-pyridy))-5.6-bis-2-(5-fury) sulfonic acid)-1,2,4-triazine, disodium salt (Ferene®). The absorbance of the complex. measured using a bichromatic (600. 700 nm) endpoint technique, is directly proportional to the concentration of transferrin-bound iron in the serum.

L. Comments on Substantial Equivalence/Conclusion:

The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ IRON Flex® reagent cartridge is substantially equivalent to the designated predicate device.

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510(k) Summary for the Dimension Vista™ IRON Calibrator

A. 510(k) Number:

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

D. Applicant:

Manufacturer: 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: June 23, 2006

E. Proprietary and Established Names:

Dimension Vista™ Iron Calibrator

F. Regulatory Information:

Regulation section: 21 CFR § 862-1150 - CALIBRATOR
Classification: Class II
Product Code: JIS - CALIBRATORS, PRIMARY

4. 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 Vista TM system.

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 Vista TM system.

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

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H. Device Description:

. Substantial Equivalence Information:

1. Predicate Device: Dimension® Iron Calibrator (DC85)
1. Predicate K Number(s): K060266

3. Comparison with Predicate:

Similarities
Item	Device	Predicate
Intended Use	To calibrate the iron method	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

J. Standard/Guidance Document Referenced:

Guidance;

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

A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications

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2. Standards;

Medical Devices - Symbols to be used with medical device labels, labeling and information to be supplied (15223), General, ISO Medical devices - Application of risk management to medical devices (14971:2000) General, ISO Stability Testing of In Vitro Diagnostic Reagents (13640), InVitro, CEN Continuous Quality Improvement: Essential Management Approaches; Approved Guideline (GP 22-A), InVitro, NCCLS

K. Test Principle:

The Dimension Vista™ Iron Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension Vista™ IRON method for the Dimension Vista™ system.

L . Comments on Substantial Equivalence/Conclusion:

The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ Iron Calibrator is substantially equivalent to the designated predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Andrea M. Tasker Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Business Community PO Box 6101, MS 514 Newark DE 19714-6101

Re: K061793

Trade/Device Name: Dimension Vista™ IRON Flex® reagent cartridge Dimension Vista™ IRON Calibrator Regulation Number: 21 CFR8862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I Product Code: JIY, JIT Dated: July 21, 2006 Received: July 24, 2006

AUG - 7 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, 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 Gutiér

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: IRON Flex® reagent cartridge

Indications for Use:

The iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

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

Prescription Use __ X (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

Page 12

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

Carol C. Benam

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061793

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Indications For Use Statement

510(k) Number (if known):

Device Name: Kold793
Dimension Vista™ IRON Calibrator

Indications for Use:

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

Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

Page 2 of 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

Carol Benson

Division Sign-Off

Office of In Vit-o Diagnostic Device Evaluation and Safety

K061793

Regulation Number and Section

§ 862.1410 Iron (non-heme) test system.

(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(b)
Classification. Class I (general 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.