Dimension Vista™ STFR Flex® reagent cartridge: The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR), methods on the Dimension Vista System.

Dimension Vista™ Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 complement (C3), C4 complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and soluble transferrin receptor (STFR) on the Dimension Vista System.

Device Description

Dimension Vista™ STFR Flex reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human soluble transferrin receptor are aggregated when mixed with samples containing soluble transferrin receptor. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liguid, human serum based product containing C3 Complement, C4 Complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and Soluble Transferrin Receptor (STFR).

Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoqlobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and soluble transferrin receptor (STFR).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista™ STFR Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a method comparison study between the new device and a legally marketed predicate device. The acceptance criteria are implicitly defined by the reported regression analysis results, which demonstrate a strong correlation and "equivalent performance" to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance (Dimension Vista™ STFR Flex® compared to N Latex sTFR on BN ProSpec® System)
Strong correlation	Correlation Coefficient: 0.997
Slope close to 1	Slope: 1.053
Intercept close to 0	Intercept: -0.078 mg/L
Equivalent performance	"These studies demonstrate correlation and equivalent performance"

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

Sample Size for Test Set: 153 serum and plasma samples.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that "serum and plasma samples with concentrations ranging from 0.21 mg/L to 4.13 mg/L" were evaluated.

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

This information is not provided in the given summary. The ground truth in this context is implicitly established by the measurements obtained from the predicate device (Dade Behring N Latex sTFR assay on the BN ProSpec® System).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the given summary. The study is a quantitative method comparison between two automated diagnostic devices, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison between two in vitro diagnostic (IVD) devices for quantitative measurement of an analyte, not a study involving human readers or interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The study directly assesses the performance of the Dimension Vista™ STFR assay on the Dimension Vista System against a predicate device, without involving human interpretation or modifications to the results.

7. The Type of Ground Truth Used

The "ground truth" for this study was established through the measurements obtained from the legally marketed predicate device, the Dade Behring N Latex sTFR assay on the BN ProSpec® System. This is a common practice in IVD device submissions to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided in the given summary. The document describes a comparison study for the finalized device, not the development or training of an algorithm.

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

This information is not provided in the given summary, as the submission focuses on the performance of the final device rather than its developmental stages or training data.

Summary

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510(k) Summary for Dimension Vista" STFR Flex® reagent cartridge

Dimension Vista™ Protein 1 Control L, M and H

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.

The assigned 510(k) number is: K063663

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:	Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany
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Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
December 7, 2006 Preparation date:
Dimension Vista" STFR Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Calibrator
Dimension Vista", Protein 1 Control M M
Dimension Vi 2. Device Name:

Classification: *	Class II; Class II; Class I
Product Code:	DDG; JIX; JJY
Panel:	Immunology (82) and Clinical Chemistry (75)

3. ldentification of the Legally Marketed Devices:

Dade Behring N Latex sTFR- K053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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4. Device Descriptions:

Dimension Vista" STFR Flex reagent cartridge

Polystyrene particles coated with monoclonal antibodies specific to human soluble transferrin receptor are aggregated when mixed with samples containing soluble transferrin receptor. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liguid, human serum based product containing C3 Complement, C4 Complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and Soluble Transferrin Receptor (STFR).

Dimension Vista" Protein 1 Control L. M and H

Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoqlobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and soluble transferrin receptor (STFR).

5. Device Intended Uses:

Dimension Vista™ STFR Flex® reagent cartridge:

The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR), methods on the Dimension Vista System.

Dimension Vista™ Protein 1 Control L, M and H:

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 complement (C3), C4 complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and soluble transferrin receptor (STFR) on the Dimension Vista System.

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

The Dimension Vista™ STFR assay, like Dade Behring N Latex sTfR is an in vitro diagnostic test for the quantitative measurement of soluble transferrin receptor in human serum and plasma.

Device Performance Characteristics: 7.

The Dimension Vista" STFR assay was compared to the Dade Behring N Latex sTR assay on the BN ProSpec® System by evaluating serum and plasma samples with

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concentrations ranging from 0.21 mg/L to 4.13 mg/L. Regression analysis of these results yielded the following equation.

Comparative Method	n	Slope	Interceptmg/L	CorrelationCoefficient
N Latex sTFR on the BNProSpec® System	153	1.053	-0.078	0.997

Method Comparison Study

8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex sTfR assay and the Dimension Vista" STFR assay.

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 1 2007

Ms. Kathleen A. Dray-Lyons Regulatory Affairs & Compliance Manager Dade Behring Inc. PO Box 6101, M/S 514 Newark DE 19714- 6101

Re: K063663

Trade/Device Name: Dimension Vista™ STFR® Reagent Cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension VistaTM Protein 1 Control H Regulation Number: 21 CFR§866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDJ, JIX, JJY Dated: February 12, 2007 Received: February 15, 2007

Dear Ms. Dray-Lyons:

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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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean m. Cooper, M.S., D.v.M.

Yéan M. Cooper, M.S., D.V.M. 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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Dade Behring Inc. sion Vista™ STFR 510(k) Notification

Indications Statement

Device Name:

Dimension Vista" STFR Flex® reagent cartridge Dimension Vista" Protein 1 Calibrator Dimension Vista Protein 1 Calibrator
Dimension Vista Dimension Vista Protein 1 Control L
Dimension Vista Protein 1 Control Million Protein 1
Dimension Vista Protein 1 Control H

Indications for Use:

Dimension Vista™ STFR Flex® reagent cartridge:

Dimension Vista" Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), lmmunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L. M and H

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and Soluble Transferrin Receptor (STFR) on the Dimension Vista® System.

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)

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

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

wision Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

K063663

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Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).