Dimension Vista™ CYSC Flex® reagent cartridge: The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

Dimension Vista™ Protein 3 Calibrator: The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.

Dimension Vista™ Cystatin C Control L and H: CYSC CON L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista® System.

Device Description

Dimension Vista" CYSC Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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 3 Calibrator: PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary cystatin C and serum albumin of human origin.

Dimension Vista" Cystatin C Control L and H: CYSC CON L and H are lyophilized, polygeline based product with urinary proteins of human origin containing cystatin C.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ CYSC Flex® reagent cartridge:

Acceptance Criteria and Study for Dimension Vista™ CYSC Flex® Reagent Cartridge

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for in vitro diagnostic devices. The acceptance criteria are implicitly defined by the goal of showing equivalent performance to the legally marketed predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The study compares the Dimension Vista™ CYSC Flex® assay against the Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System. The acceptance criteria are based on achieving strong correlation and a specific relationship between the new device and the predicate.

Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Dimension Vista™ CYSC Flex® vs. Predicate)
Number of Samples (n)	Sufficient for statistical significance (not explicitly stated)	160
Slope	Close to 1.0 (indicating proportional agreement)	1.005
Intercept	Close to 0.0 (indicating no significant systematic bias)	0.005
Correlation Coefficient	Close to 1.0 (indicating strong linear relationship)	0.998

Conclusion: The reported device performance meets the implicit acceptance criteria, demonstrating a very strong correlation and comparable results to the predicate device. The slope of 1.005 is very close to 1, the intercept of 0.005 is very close to 0, and the correlation coefficient of 0.998 is indicative of excellent agreement.

2. Sample Size and Data Provenance for the Test Set

Sample Size Used for the Test Set: 160
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given that it's a method comparison study evaluating serum and plasma samples, it's likely a prospective collection of samples to perform the comparison, or retrospective use of banked samples, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

The study described is a method comparison study between two assays, not a study requiring expert interpretation to establish ground truth for a diagnostic condition. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) does not directly apply here. The "ground truth" for the test set is effectively the results obtained from the predicate device (Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System), which is a legally marketed device.

4. Adjudication Method for the Test Set

As this is a method comparison study with a predicate device serving as the reference, an adjudication method in the context of expert consensus (like 2+1 or 3+1 for imaging studies) is not applicable. The comparison is quantitative, based on the numerical results from both assays.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret cases, often with and without AI assistance, to measure the impact of AI on reader performance. The Dimension Vista™ CYSC Flex® reagent cartridge is an in vitro diagnostic assay, which does not involve human interpretation in the same way.

6. Standalone (Algorithm Only) Performance

The study presented is essentially a standalone performance assessment of the Dimension Vista™ CYSC Flex® assay compared to a predicate quantitative assay. There is no human-in-the-loop component mentioned for the analytical performance determination. It's the performance of the automated system and reagents.

7. Type of Ground Truth Used

The "ground truth" for this method comparison study is the quantitative results obtained from the legally marketed predicate device: the Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System. This serves as the reference standard against which the new device's performance is measured.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. This summary describes the validation study (test set), not the development or training of the assay. For an in vitro diagnostic kit, "training set" might refer to samples used during the assay development and optimization phases, which are typically not detailed in a 510(k) summary focused on validation.

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

Since a training set sample size is not provided, the method for establishing its "ground truth" is also not described. For IVD assays, the "ground truth" during development often involves extensive analytical characterization, spiking experiments, linearity studies, and comparisons to established reference methods or certified reference materials, but these details are not present in this summary.

Summary

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

Dimension Vista" Cystatin C Control L 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.

er is: K06335|

The assigned 510(k) number is: 10(03335
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
---------------	-----------------------------------------------------------------------------

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
Preparation date: November 3, 2006
Dimension Vista™ CYSC Flex® reagent cartridge 2. Device Name: ionsholor Vista" Protein 3 Californian 3 Calibration
Dimension Vista", "Protein 3 Calibration Claiman
Dimension Vista", "Cystation Coontrol L

Classification:	Class II; Class II; Class I
Product Code:	NDY; JIX; JJY
Panel:	Clinical Chemistry (75)

3. Identification of the Legally Marketed Device:

Dade Behring N Latex Cystatin C Kit- K041878 Dade Behring N Protein Standard UY - K003501

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Device Description: 4.

Dimension Vista" CYSC Flex® reagent cartridge

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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 3 Calibrator

PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary cystatin C and serum albumin of human origin.

Dimension Vista" Cystatin C Control L and H

CYSC CON L and H are lyophilized, polygeline based product with urinary proteins of human origin containing cystatin C.

5. Device Intended Use:

Dimension Vista" CYSC Flex® reagent cartridge:

The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

Dimension Vista™ Protein 3 Calibrator:

The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.

Dimension Vista" Cystatin C Control L and H:

CYSC CON L and H are assayed intralaboratory quality control for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista" System.

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

The Dimension Vista "CYSC assay, like the Dade Behring N Latex Cystatin C Kit is an in vitro diagnostic test for the quantitative measurement of cystatin C in human serum and plasma.

7. Device Performance Characteristics:

The Dimension Vista" CYSC assay was compared to the Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.33 to 7.46 mg/L. Regression analysis of these results yielded the following equation:

Comparative Method	n	Slope	Intercept	Correlation Coefficient
N Latex Cystatin C on the BNProSpec®	160	1.005	0.005	0.998

Method Comparison Study

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Dade Behring Inc.
Dimension Vista 510(k) Notification

8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex Cystatin C Kit and the Dimension Vista" CYSC assay.

000096

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird-like figure with three wing-like shapes extending upwards.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, DF 19714

JAN 2 2 2007

Attn: Kathleen A. Dray-Lyons

Re: K063351

Trade/Device Name: Dimension Vista™ CYSC Flex® reagent cartridge, Dimension Vista™ Protein 3 Calibrator, Dimension Vista™ Cystatin C Control M & Dimension Vista™ Cystatin C Control H Regulation Numbers: 21 CFR 862.1225 Regulation Names: Creatinine test system Regulatory Class: Class II Product Code: NDY, JIX & JJY Dated: November 3, 2006 Received: November 6, 2006

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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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) 276-0490. 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., Dimension Vista 510(k) Notification

Indications Statement

K0463351/

Device Name:

"" CYSC Flex® reagent cartridge Dimension Vista Dimension Vista - CrSC Frex - Protein 3 Calibrant C
Dimension Vista - Protein 3 Calibraon Mistan M
Dimension Vista - Cystating Control M
Dimension Vista - Cystating Control M Dimension Vista" Cystatin C Control M
Dimension Vista" Cystatin C Control H

Indications for Use:

Dimension Vista™ CYSC Flex® reagent cartridge:

Dimension Vista™ Protein 3 Calibrator:

The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.

Dimension Vista™ Cystatin C Control L and H:

CYSC CON L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in determination of cystatin C (CYSC) 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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of _

Carol Benson
Division Sign off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

3199(k) K063351

000055

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.